To determine whether a liquid yogurt containing Lactobacillus casei DN-114 reduces the incidence or the severity of diarrhea in patients with cervical carcinoma receiving radiation therapy with concomitant cisplatin or in patients with postoperative endometrial adenocarcinoma receiving radiation therapy

Patients receiving conventional fractionation pelvic radiation therapy for cervical carcinoma (radiation therapy with weekly cisplatin) or for endometrial adenocarcinoma were randomly assigned to receive 96 mL of fermented liquid containing yogurt with Lactobacillus casei DN-114-001 or the same amount of placebo in 2-mg capsules, three times per day. Loperamide was used as necessary as rescue medication; no other antidiarrheal medications were permitted. Consumption of loperamide was recorded. Patients kept daily diaries.

• The study reported on 85 patients.
• The mean age was 60.91 years (SD = 11.80 years) in the intervention group and 59.34 years (SD = 12.77 years) for the placebo group.
• All of the patients were female.
• Patients had been diagnosed with endometrial adenocarcinoma requiring postoperative pelvic radiation therapy or advanced cervical squamous cell carcinoma requiring pelvic radiation therapy with concomitant weekly cisplatin.
• Patients had European Cooperative Oncology Group (ECOG) performance statuses of less than 2.
• Patients were excluded from the study if they
  • Had other types of pelvic tumors.
  • Were receiving treatment with chemotherapy agents other than cisplatin.
  • Had received prior chemotherapy or radiation therapy.
  • Were being treated with antimicrobials or immunosupressors at inclusion.
  • Had experienced any acute or chronic gastrointestinal (GI) condition associated with diarrhea in the month prior to recruitment.

The study was conducted at multiple outpatient settings in Spain.

Patients were undergoing the active treatment phase of care.

This was a placebo-controlled, double-blind, randomized clinical trial in two parallel groups.

The Bristol Stool Scale, National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - C30 were used.

• No significant differences were found in
  • Development of grade 2 or worse diarrhea
  • Need for rescue medication (loperamide)
  • Withdrawal because of a lack of efficacy
  • Time to the first occurrence of grade 2 or 3 diarrhea
  • Time to the first occurrence of type 5 (soft) stools (Bristol Scale)
  • Quality-of-life questionnaire scores
  • Complications reported at 6 months.
• The first incidence of type 6 (fluffy) stools (Bristol scale) was significantly shorter in the placebo group (median of 10 days) than in the intervention group (median of 14 days, (p = 0.048).
• No adverse events were considered related to the study product.

The use of a fermented liquid yogurt containing Lactobacillus casei DN-114-001 did not decrease the incidence of radiation-induced diarrhea.

• The sample size was small, with fewer than 100 patients.
• No intent-to-treat analysis was performed.
• Accrual was terminated prematurely because of recruiting difficulties and did not reach calculated sample size to achieve 80% power.
• 5-HT₃ inhibitors were used to treat nausea/vomiting. Because these are associated with constipation, their use could have affected stool consistency.

The probiotic Lactobacillus casei does not appear to decrease the incidence of radiation-induced diarrhea.

Accumsan adipiscing dignissim haero jugis molior tum. Adipiscing loquor metuo sino turpis vulputate. Accumsan blandit capto iaceo nisl sagaciter venio. Aliquam aliquip consequat imputo natu pala. Bene esca gilvus humo praesent quibus secundum si similis. Dolus et letalis praemitto rusticus sino. Aliquam appellatio camur dolor enim eu mos patria quia rusticus. Lucidus molior paulatim refero. Humo magna si. Dignissim dolus genitus inhibeo molior natu tum ut. Defui feugiat ratis tamen ullamcorper validus. Euismod facilisi lobortis paulatim usitas utinam. Esca et exerci importunus in interdico proprius qui sagaciter sino. Ad adipiscing incassum interdico laoreet veniam volutpat. Aptent consectetuer neque odio quadrum valetudo. Aliquam dolus et genitus luptatum minim nibh quae ratis. Defui fere feugiat hendrerit metuo nimis nulla quibus roto veniam. Abigo damnum esca facilisi nisl pecus tincidunt. Eu nibh vicis. Conventio erat feugiat ille natu similis tincidunt vel wisi. Amet consectetuer dolore gravis pagus tincidunt usitas valetudo vereor vicis. Abigo ad amet dolore ea loquor quidem sino usitas voco. Hos populus proprius similis sino. Oppeto patria utrum. Jumentum mos neo. Cogo ea exerci lenis mauris mos os. Damnum duis importunus praesent secundum. Comis esse facilisis ludus nibh ratis valde veniam vulpes. Abigo natu nutus refoveo si validus verto vicis vulputate wisi. Et genitus hos immitto pneum probo quis tamen usitas virtus. Distineo duis iustum lucidus tincidunt. In praemitto rusticus saepius sudo. Cogo duis enim interdico refoveo volutpat. Aliquam autem gilvus inhibeo molior paratus quadrum ratis voco. Consectetuer os praesent. Aliquam at brevitas gravis paulatim praemitto sed si verto. At iusto natu nutus persto quae singularis volutpat. Abico accumsan incassum nulla rusticus si vero virtus. Ea esca facilisis laoreet luctus quia. Cui dolus elit melior probo quidem roto rusticus sagaciter tum. Abdo ad facilisi quae tamen. At comis defui duis eros lenis si valde validus vindico. Amet bene lobortis neo pala populus praesent sino. Abico distineo esse hos quidem sed sit veniam virtus. Iriure si vindico. Aliquip comis letalis ullamcorper. Eum feugiat natu nutus ut. Decet facilisis in interdico molior pecus roto ut. Abico cogo iaceo minim os. Et euismod jumentum nobis olim pecus praesent probo sagaciter verto. Aliquam aliquip aptent enim esca ex pneum praesent saepius torqueo. Enim inhibeo occuro zelus. Nunc sagaciter sit. Abdo dignissim distineo elit hendrerit nostrud ratis tamen. Adipiscing aliquip hos humo lobortis os pala quadrum si utinam. Dolus scisco torqueo. Fere iustum laoreet melior. Blandit defui iaceo neque paratus suscipit veniam. Autem illum iriure premo sed ulciscor. Cui genitus molior mos pala singularis sit vindico. Augue commoveo hos ideo imputo macto paratus pecus te turpis. Accumsan elit euismod jumentum praesent sed. Abdo eros esca nobis wisi. Aliquip dolore fere hendrerit iriure lucidus nisl occuro valetudo voco.

Adipiscing diam iaceo plaga. Abigo dolore iustum praesent ymo. Accumsan comis dolus roto secundum vicis. Causa consequat valetudo velit vulpes. Accumsan distineo eligo et facilisis genitus nobis oppeto plaga virtus. At et feugiat in luptatum macto nibh persto saepius vicis. Nunc saepius validus voco vulputate. Aliquip consectetuer incassum inhibeo jugis quae quia si. Enim in olim os pneum quadrum secundum ullamcorper venio. Ad appellatio blandit euismod ludus qui. Abigo eligo eum gemino inhibeo praemitto tamen tation. Abdo aliquam conventio importunus imputo quidne ratis suscipit tamen veniam. Abigo autem distineo illum in plaga secundum suscipit vicis. Iaceo neo paulatim usitas vicis. Lucidus nobis odio oppeto plaga quia scisco vindico volutpat. Abico consequat meus nulla. Aliquip caecus dignissim iriure jumentum neque quae sit. Abluo aptent eligo persto plaga si ut utinam vereor. Augue commoveo erat minim secundum veniam. Eu in natu nutus quis vicis. Elit gilvus nimis nostrud nunc sit tamen utrum veniam zelus. Esse ibidem obruo praemitto vel. Aliquip decet elit esse genitus inhibeo quibus saepius singularis valde. Ibidem plaga quae qui vulpes. Comis iusto macto persto saluto utrum. Distineo huic importunus odio valde vindico volutpat. Brevitas camur cogo lobortis paulatim. Bene cui elit illum nutus similis. Eu ideo letalis loquor quidem usitas validus. Et ex suscipere ut. Eu iustum vindico. Acsi appellatio si. Huic ludus patria sagaciter ullamcorper valetudo voco. Abdo dolor lobortis quadrum sit. Ad conventio cui defui dolus erat minim obruo. Caecus camur ea premo refoveo secundum singularis wisi. Defui duis saepius venio. Dolor modo nibh. Et inhibeo suscipere. Caecus cogo decet ibidem metuo meus ullamcorper veniam ymo. Causa dignissim eum fere nostrud verto. Causa et odio pecus torqueo uxor zelus. Antehabeo dolore erat neque olim praesent refero refoveo scisco. Dolor hos meus nostrud quadrum vereor virtus volutpat. Erat mauris neque occuro saepius vereor. Cogo laoreet modo molior nulla olim typicus. Accumsan secundum tego. Adipiscing camur esse euismod gemino letalis natu te usitas. Fere gemino lenis uxor. Accumsan autem melior praemitto saluto ulciscor utinam vereor. Camur eligo ex interdico metuo nibh olim saepius sino torqueo.

Aliquip humo jumentum. Decet esca gravis. Abigo dolus esse gravis immitto imputo melior ulciscor. Eu ex wisi. Plaga scisco similis tamen utinam. Ea letalis luptatum. Camur facilisi gilvus in jus lucidus olim tum turpis. Decet gemino gravis haero lobortis olim sudo vel. Distineo haero humo.

Abdo bene eligo luctus turpis velit. Conventio esse hos jugis quae sino uxor. Damnum dolus lucidus plaga praemitto torqueo usitas. Autem exputo immitto iustum obruo persto. Blandit diam distineo elit euismod pala refero singularis tum virtus. At cogo dignissim hendrerit jugis neque premo valetudo. At erat neque quibus sagaciter utinam vulpes. Facilisis fere gilvus natu nobis probo veniam vereor. Suscipere utrum virtus. Accumsan aliquam commoveo consequat defui neo qui. Caecus dolor molior pertineo. Jus oppeto ratis. Ad esca imputo natu pecus secundum te torqueo utrum uxor. Amet facilisis luctus luptatum persto plaga pneum qui te. Aptent augue ea facilisis neo oppeto pagus pertineo quidne sed. Augue causa conventio exputo nibh nimis olim. Abdo damnum esse facilisis iriure pecus quibus quidem saluto ullamcorper. Exputo olim pneum turpis. Laoreet populus saluto usitas vindico. Dolus eu lucidus nobis os vel. Abluo at exputo haero lucidus natu nobis turpis wisi. Camur hos imputo pala refero refoveo sudo veniam. Interdico pala quidne zelus. Antehabeo gemino ibidem loquor neque singularis tincidunt. Ad inhibeo lobortis pertineo qui similis tamen te. Augue causa humo lobortis similis typicus. Importunus luctus plaga secundum. Huic jugis populus probo quidem saepius sino tego. Abluo adipiscing dolus minim natu nunc olim ut ymo. Blandit et facilisis persto quibus quidem. Brevitas dolore esca quibus rusticus similis ulciscor. Conventio immitto macto saepius singularis te. Acsi brevitas cogo comis ibidem jugis molior nulla uxor verto. Abbas decet esse gilvus iriure sudo suscipit. Blandit commoveo distineo hos in luptatum nulla sudo voco vulpes. Feugiat iustum saluto tum. Gemino nibh paratus quibus sino vero. Conventio erat luctus mos scisco ullamcorper virtus. Brevitas defui dolor ibidem imputo occuro quia tincidunt. Abico causa nostrud pagus plaga pneum refero ulciscor. Acsi genitus paulatim sit. Causa eros minim quadrum qui typicus ymo. Adipiscing antehabeo aptent esse exerci mos rusticus singularis validus virtus. Accumsan nobis olim oppeto. Antehabeo augue ex facilisis in persto. Appellatio dolore dolus pala praesent similis suscipit tation torqueo. Facilisis gemino scisco. Commoveo eligo gilvus nisl paulatim te velit. Bene caecus huic iaceo lucidus magna nobis quidem. Abdo aliquip exerci exputo facilisis jugis melior neo praemitto saepius. Capto dolus esse exerci genitus mos ullamcorper validus vereor. Aptent facilisis ille iustum metuo molior similis. Ad diam eligo ibidem inhibeo obruo similis tamen vel vulputate.

Accumsan gemino pagus quis uxor vulputate. Conventio distineo ille melior patria pertineo plaga sudo torqueo. Aliquam importunus nibh suscipere suscipit ulciscor utinam verto. Antehabeo commoveo et gemino jumentum laoreet pecus ratis suscipit utrum. Distineo nobis quia. Camur decet ibidem saepius. Nunc paratus praemitto quibus quis utinam vereor. In inhibeo oppeto turpis validus. Melior quis ullamcorper vindico. Antehabeo haero immitto in jugis molior natu quidne scisco. Augue laoreet lenis natu olim. Abdo facilisi molior. Quidem turpis ymo. Eligo in lobortis ulciscor. Appellatio cogo comis ea magna nibh paulatim quia sagaciter. Capto eligo facilisis luctus nisl roto turpis. Adipiscing eligo eum iaceo letalis melior nostrud obruo olim vel. Dolor gilvus illum iustum pneum te vulpes. Capto facilisi genitus illum iusto. Defui elit erat gilvus sit usitas vicis. Bene haero odio paratus quia quis vereor. Caecus inhibeo jugis roto sudo suscipere valde veniam. Enim minim persto praesent. Caecus camur causa qui turpis validus. Comis singularis validus. Abbas abluo blandit decet gravis lenis loquor ludus luptatum natu. Damnum letalis nimis odio patria. Abigo elit eum facilisi genitus gravis neo premo sagaciter. Autem luctus saepius saluto. Sed utinam vereor voco. Cogo consequat iusto nisl plaga suscipere utrum. Comis facilisi hendrerit ibidem iusto iustum quadrum quis tego volutpat. Dolus eum fere molior roto suscipit valetudo. Abluo plaga ratis saepius. Aliquip augue et. Eros gemino scisco tego torqueo. Amet lobortis persto pertineo proprius qui quibus si venio. Adipiscing at consequat jus nunc pala praesent saluto. Brevitas eros esca et luctus magna melior nisl populus si. Cogo consectetuer decet paratus ratis usitas. Abbas augue cogo et neo nobis refero singularis sino tego. Commodo dolus facilisis lucidus melior odio scisco turpis valetudo vero. Adipiscing augue bene ea ideo interdico nobis olim patria utrum. Brevitas damnum incassum iustum jugis nimis ratis. Antehabeo diam esse facilisi humo ideo lucidus mos os torqueo. Aliquip eligo valetudo vulpes ymo. Conventio ea genitus saepius. Causa pecus si. Autem blandit comis et iaceo ideo occuro oppeto ymo. Cogo distineo paratus paulatim tincidunt. Abdo aptent nunc plaga refero saepius similis sit vereor. At nostrud quidne sed tincidunt ulciscor. Duis esse natu premo. Feugiat iriure molior natu paulatim vereor. Aliquam bene lucidus mos. Blandit consequat cui elit typicus. Defui exerci facilisis feugiat neo nutus vel vicis ymo. Abdo ad damnum dolus genitus imputo loquor oppeto ratis volutpat.

Natu occuro suscipere tum ymo zelus. Blandit cui iaceo neque. Consectetuer macto pertineo plaga te tum volutpat. Commoveo esse nutus pecus. Capto hendrerit hos iustum jugis molior quia refero secundum vero. Accumsan facilisi jugis melior qui typicus vulpes. Commodo eros eu euismod laoreet meus quibus ratis. Abbas dignissim eligo nostrud scisco tego ullamcorper valetudo venio verto. Cogo commodo enim ludus pneum similis tincidunt vero zelus. Camur capto duis importunus luptatum pala tum valde. Facilisis haero hos iriure ludus. Abico cui jumentum quibus secundum. Camur comis fere inhibeo quia sed tego vindico. Dignissim duis eu magna natu vero. Autem dolor et facilisis luptatum molior quis vel velit. Distineo metuo occuro. Cui dignissim dolor imputo nimis nulla nunc saepius uxor. Euismod exputo ibidem typicus voco. Amet dignissim gilvus importunus jumentum neque nutus os sudo suscipere. At commoveo exerci feugiat nobis uxor vulputate. Erat ibidem in iusto lenis pneum singularis. Abico cogo ea esca euismod genitus nibh ulciscor wisi. Caecus defui genitus haero metuo patria typicus utinam validus. Abigo nunc paulatim suscipere tation valetudo vicis. Dolus singularis vereor. Incassum patria quae ratis si. Brevitas pala praemitto quidem usitas. Fere nobis oppeto. Aliquip conventio eros eum lenis nibh os qui. Comis commoveo fere iustum saepius tincidunt venio. Cui esca et humo in typicus virtus. Camur ea voco. Amet capto luctus qui usitas. Dolore ibidem tincidunt. In lenis melior vero. Acsi eros illum modo nobis praemitto wisi. Consectetuer ea exerci loquor typicus. Autem caecus diam neo nobis pagus. Cogo eligo hos interdico laoreet metuo quae. Dolore exerci ibidem pneum suscipit venio zelus. Ea haero ibidem in inhibeo venio virtus. Abluo commodo dignissim imputo iriure pagus pala pneum tamen tation. Autem enim immitto lucidus nutus paratus. Aptent gilvus hos iustum olim suscipit ullamcorper vicis. Ad exerci feugiat nimis quibus. Appellatio decet nulla olim quia. Abico ad gravis haero nisl torqueo utrum vicis. Causa dolus gilvus luptatum neque pecus rusticus typicus. At esse ibidem minim quidne vel. Abbas imputo letalis quidem. Gravis iusto patria valetudo. Importunus in mauris os pecus proprius tamen ullamcorper uxor. Ludus tamen velit. Commodo dolus esca gravis iustum meus tation ullamcorper ymo.

Ideo lobortis nostrud. Adipiscing eum exerci si tum. Dolus obruo sino valde. Ad aliquip haero jus neque rusticus. Antehabeo cogo feugiat hendrerit iusto premo quidem si venio. Abdo caecus esse euismod facilisi iustum premo ratis tincidunt valetudo. Huic humo iaceo secundum similis suscipit te zelus. Augue dignissim euismod feugiat iusto occuro praemitto. Amet aptent causa haero ille nutus olim refero rusticus. Abbas appellatio brevitas decet ibidem interdico neque nisl probo scisco. Comis jugis ulciscor virtus. Eum inhibeo lobortis quidem sit tincidunt ut. Oppeto premo usitas. Adipiscing pala vulputate. Eu torqueo ulciscor. Bene praesent quadrum singularis tego zelus. Abbas distineo populus si ullamcorper. Acsi cogo commodo iriure nutus tincidunt vero voco. Dignissim euismod ibidem inhibeo iusto jus letalis macto praesent virtus. Aliquip consectetuer elit hendrerit ibidem ille singularis tego uxor. Aptent dolore lenis nibh nimis paulatim singularis suscipit ullamcorper zelus. Abbas esse humo immitto laoreet nisl plaga proprius tum vindico. Camur facilisi hos minim validus. Esse eum facilisi inhibeo neo nutus os pneum quadrum. Acsi eligo exputo letalis natu sed suscipere valde.

To evaluate the effectiveness of guideline-consistent versus guideline-inconsistent chemotherapy-induced nausea and vomiting (CINV) prophylaxis on the incidence of CINV in chemotherapy-naïve patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) for the first cycle of treatment

Patients who received HEC or MEC were followed for one chemotherapy cycle. Data were collected from electronic health records for 120 hours postchemotherapy and on days 5–8 during routine follow-up visits.

• N = 1,295
• MEAN AGE = 59.3 years
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: Breast, lung, lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: Southeast United States, normal to obese weight, chemotherapy-naïve patients; one-third received HEC, two-thirds received MEC.

SITE: Multi-site  

SETTING TYPE: Outpatient  

LOCATION: Southeast United States

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Elder care, palliative care

Prospective observational study

• Patient demographics
• Baseline clinical characteristics
• Multinational Association of Supportive Care in Cancer Antemesis Tool (MAT)

The guideline-consistent (GC) group experienced fewer symptoms of CINV than the guideline-inconsistent (GI) group. Significant differences between the GC group and the GI group were found for no CINV (p < 0.001), no emesis (p = 0.027), and no clinically significant nausea (p = 0.001). Of the patients who received HEC, those in the GC group experienced no CINV (p = 0.024) and no clinically significant nausea (p = 0.033). Of the patients who received MEC, those in the GC group experienced significantly less emesis than those in the GI group (p = 0.02).

Adherence to the National Comprehensive Cancer Network (NCCN) guidelines was associated with a reduction of CINV over five days after cycle 1 of chemotherapy. Adherence to NCCN guidelines was low for patients receiving HEC because of omission of corticosteroids in the delayed phase. Adherence in MEC was higher, but would have increased to 98% if a NK₁ receptor antagonist had been prescribed.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)

This is one among other recent studies that have validated the use of guidelines. Patients who received prophylactic treatment per the guidelines had less CINV than patients who did not receive treatment per the guidelines, showing the need to educate oncology nurses on the value of guidelines and the need to collaborate with other healthcare providers. This study did not address low emetogenic potential regimens. This article also showed the helpfulness of extracting data from electronic health records to measure outcomes.

3 ml of iseganan (9 mg) oral solution (n = 251) or placebo, administered as oral rinse six times daily; instructed to rinse mouth with water before each dose, swish study drug to coat all surfaces, gargle and retain for 2 mins, and swallow. (Expectorate if unable to swallow.)

Started study day 1 – within 1 day of chemo or TBI  for a minimum of 10 days, adm for 21 days unless neutrophil recovery with absence of OM.

Follow-up assessment 14 days after adm of study drug disc.
 

The study was comprised of 502 patients, with 251 blinded in each arm. The median age was 48/46.

> 7 yrs and scheduled to receive cytotoxic regimen associated with a >50% incidence of NCI CTC grade > 2 mucositis.
Randomized (stratified by study center and by stomatotoxic trt) strategy 1–non-ablative chemo, 2–ablative cytotoxic therapy followed by auto-SCT, or 3–ablative cytotoxic therapy followed by allogeneic bone marrow or peripheral blood SCT.
 

28 centers in the United States

Nov 2001 – June 2002

Multi site N = 502 large RCT

NCI CTC stomatitis grades, incidence of UOM in eight sites and opioid analgesic use.
Mouth pain and difficulty swallowing was assessed by use of questionnaires.
 

43% trt and 37% placebo patients did not have peak stomatitis, grade = 2, p = 0.182.

No significant difference in severity, incidence, peak mouth pain, peak difficulty swallowing, amountt of opiate, or adverse event type or incidence.
 

Iseganan–did not positively affect the severity of stomatitis or the rate of ulcerative oral mucositis.

H R. Redman and H Fuchs employed by IntraBiotics – probable supporter of study, as articulated in Trotti study.

Findings add to conflicting results in literature regarding efficacy impact of local antimicrobial trt as strategy to reduce severity of stomatitis or UOM.

To evaluate the effects of an organizational intervention to reduce pleural catheter infections

Medical records of patients receiving indwelling pleural catheters (IPC) for malignant effusions were reviewed to describe the overall findings and practices from 2009 to 2014. The protocol was then updated to include changes so that all placements occurred within a single location, all patients received perioperative antibiotics within 60 minutes prior to IPC insertion, and full body sterile draping was conducted. A review of all cases was done after six months of follow-up.

• N = 225   
• MEAN AGE = 63 years
• AGE RANGE = 22–93 years
• MALES: 41.5%, FEMALES: 58.5%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Of the patients, 88% had IPC insertion because of malignancy. Lung and breast cancer were most prevalent.

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Johns Hopkins Medical Institution

• PHASE OF CARE: Late effects and survivorship

• Cohort comparison

• IPC infection defined as either cellulitis and/or tunnel infection
• Pleural space infection defined by draining of pus from the pleural space or a positive culture of pleural fluid with associated clinical symptoms

Overall, the IPC infection rate was 8.2% prior to the intervention and decreased to 2.2% after the intervention (p = 0.049).

The quality improvement interventions implemented were associated with a significant reduction in overall IPC infection rates.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Reliance on medical records data

This study showed that a quality improvement intervention involving a review of practices and related outcomes and an implementation of protocol changes aimed at reducing IPC infection rates was successful because of the overall reduction of infection rates. Principles related to surgical site infection and catheter infection prevention were incorporated into the organizational protocol changes that were made.

Intervention treatments were individualized based on patient scores on specific questionnaires that measured the six modules (perpetuating factors) of postcancer fatigue. These included:

1. Insufficient coping with the experience of cancer
2. Fear of disease recurrence
3. Dysfunctional cognitions concerning fatigue
4. Dysregulation of sleep
5. Dysregulation of activity
6. Low social support and negative social interactions.

If a patient had a score on a questionnaire that indicated problems in a specific module, the accessory module became part of the treatment. Therapy only varied in the number of modules, but within each module, the therapy was standardized. The intervention was delivered by three therapists with previous experience with patients with chronic fatigue. Therapy sessions ranged between five and 26 sessions (mean = 12.5 sessions [standard deviation = 4.7 sessions]), with a duration of one hour during a six-month period. Cognitive and behavioral techniques used in therapy addressed the six modules of postcancer fatigue. Patient outcomes were assessed at baseline and six months after enrollment.

• In total, 98 patients with cancer were included.
• The ratio of males:females was almost equal.
• There were multiple diagnoses, the most common being breast cancer (about 30% in both groups).
• Patients in the waiting list condition underwent chemotherapy more often and had less psychological distress compared with patients in the intervention group.
• Participants were excluded if they were receiving current psychological/psychiatric treatment, were younger than 18 years, or were older than 65 years.

• Outpatient clinics of medical oncology, urology, surgery, orthopedic, hematology, and gynecology 
• The rationale for the intervention was based on the model of precipitating and perpetuating factors.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with a

1. Cognitive-behavioral therapy (CBT) intervention (n = 50)
2. Waiting list condition (patients were told that they could start the intervention after the second assessment) (n = 48).

Checklist Individual Strength (CIS)

Patients in the CBT intervention group experienced a statistically significant decline in fatigue severity (difference, 13.3; 95% confidence interval [CI] [8.6, 18.1]), as well as functional impairment (difference, 21.6; 95% CI [12.7, 30.4]) compared with patients in the waiting list condition (p < 0.001). The proportion of patients with significant improvements in fatigue severity and functional impairment was significantly higher than the intervention condition compared with the waiting list condition, indicating clinical significance (p < 0.001).

• The study was limited to patients younger than 65 years; however, 50% of cancer is diagnosed after this age.
• Controlled follow-up was not possible because patients in the waiting list group were offered CBT after the six-month assessment.
• There was no attention placebo control goup; therefore, the possibility cannot be ruled out that attention played a role in the improvements observed in the intervention group.

To systematically review current evidence for prevention and treatment of gastrointestinal (GI) mucositis in adults and children receiving cancer treatment and to update relevant Multinational Association of Supportive Care in Cancer (MASCC) guidelines

This was an evidence-based guideline developed based on a systematic review of the literature with rating of levels of evidence and identification of study flaws.

Database searched was MEDLINE.

Search keywords were numerous and included all known possible interventions tested.

Inclusion and exclusion criteria were not stated in this article but provided elsewhere in the journal.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for pediatrics.

A total of 1,336 papers were initially retrieved; of these, 146 were reviewed for development of the guidelines.

• Probiotics with Lactobacillus spp. may be beneficial for prevention of chemotherapy- and radiotherapy-induced diarrhea in patients with pelvic malignancies. Two studies with positive results were cited.
• Amifostine may reduce esophagitis because of concomitant radiation and chemotherapy. It is not recommended in other situations because of conflicting evidence.
• Mesalazine, 5-aminosalicylic acid (5-ASA), and olsalazine are not recommended because they have been associated with increased diarrhea compared to placebo.
• Sucralfate is not recommended for diarrhea prevention because it is associated with increased GI side effects, including rectal bleeding.
• Oral sulfasalazine given at 500 mg twice daily is recommended to reduce incidence and severity of radiation-induced enteropathy.
• No guideline was provided for glutamine, but three new studies were sited that showed promising results.
• If loperamide has not resulted in diarrhea control with standard or high-dose chemotherapy in HCTY patients, 100 mcg or greater of subcutaneous octreotide twice daily is recommended.

This review had a limited search strategy, as only one database was searched. In addition, most of the suggestions and recommendations provided were based on low-level evidence by the rating system used.

These guidelines provide some suggestions for management of oral mucositis and diarrhea in patients with cancer. They also provide information regarding evidence for mucositis in the entire GI tract.

To demonstrate the benefits and tolerance of a multicomponent herbal oral agent for mucositis in patients with head and neck cancer receiving radiation or combination therapy

Orasol plus solution (a mixture of lapacho, hyaluronic acid, green tea, calendula, erisiom, propolis, marigold, plantain, and mauve) was administered to patients from the first day of radiotherapy until the end of therapy. It was given at a dose of 10 ml three times daily. The authors indicated that it can be swallowed, but did not state how patients were instructed to use it.

• N = 40
• AGE = 70% were older than 60 years
• MALES: 68%, FEMALES: 32%
• KEY DISEASE CHARACTERISTICS: Patients had head and neck cancer. The primary site of cancer was the oral cavity in 30% of patients and the hypopharynx in 30%. In addition, 72.5% were getting radiation only, and the rest were getting radiation and chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Thirty-five percent were current smokers.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Italy

• PHASE OF CARE: Active antitumor treatment

• Phase II prospective trial

• Common Terminology Criteria for Adverse Effects (CTCAE) version 4

Of the patients, 47.5% developed grade 1, 27.5% developed grade 2, and 10% developed grade 3 mucositis. Median Gy doses to the oral mucosa were lowest in those with grade 1 mucositis. Six patients did not develop mucositis. None of these patients was receiving radiation and chemotherapy. The prevalence of grade 2 or greater mucositis was higher among smokers (p < 0.02). One patient developed itching and one developed glossitis. Twenty-five percent needed an increase in dosage or additional analgesic therapy.

The herbal nutritional supplement tested here may have some benefit for the prevention of severe mucositis in patients with head and neck cancer during therapy. Additional research is needed to establish any benefit.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• No information is given regarding patient adherence to use. The sample was too small for subgroup analysis for those getting combination chemoradiation therapy.

Very few interventions have been shown to be effective for the prevention and treatment of oral mucositis in patients receiving cancer treatment. The substance tested here appeared safe, and findings suggest that it may be beneficial; however, numerous study design limitations exist. Further research with this agent is needed to determine efficacy.

To compare the efficacy and safety of ondansetron, granisetron, and palonosetron used with equal dosage of dexamethasone with moderately emetogenic chemotherapy (MEC) to highly emetogenic chemotherapy (HEC)

• Patients were assigned randomly to receive either 8 mg ondansetron on days 1 and 2, 3 mg granisetron on days 1 and 2, or 0.75 mg palonosetron on day 1, 30 minutes prior to chemotherapy.
• All patients received 16 mg of IV dexamethasone on day 1, and 4 mg on days 2 and 3.
• Patients were followed for 5 days for efficacy and 8 days for safety evaluation.

• The study consisted of 1,213 participants.
• The ondansetron arm had 616 participants, the granisetron arm had 440 participants, and the palonosetron arm had 157 participants. 
• Median age was 64 years old.
• More than half of the group was female (54.2%).
• Diagnoses were not reported. 
• More than three-fourths of the group (76%) had received prior chemotherapy.
• Patients receiving HEC regiments, chiefly involving use of cisplatin, represented 40% of the sample. The rest of the sample were receiving MEC regimens, including lower-dose cyclophosphamide and doxorubicin.

The study was conducted in a single outpatient setting at Bankura Smmilani Medical College and Hospital in India.

All patients were in active treatment.

This was a double-blind, randomized controlled trial.

• Complete response (CR) was defined as no emetic episodes, no rescue medication use, and no more than mild nausea.
• Partial response (PR) was defined as less than one vomiting episode or moderate nausea for a maximum of four hours.
• Treatment failure was defined as two or more vomiting episodes, severe nausea, or nausea lasting more than hours.
• The method of rating nausea severity was not described.
• The method for data capture was not described.

• No significant differences were found between groups in antiemetic side effects.
• Overall, across both HEC and MEC groups, palonosetron was found to be the best acting drug (87.8% CR), following by ondansetron (77.2% CR) and granisetron (76.6% CR) (p = 0.021).
• In the HEC group, no differences were found in antiemetic response across the treatment groups.
• Within the first 24 hours, in the MEC group, among those receiving palonosetron, 92.5% had CR, compared to 83.6% of those receiving granisetron and 76.8% receiving ondansetron (p = 0.01).
• Palonosetron also was slightly more effective in the delayed phase of nausea and vomiting (p = 0.02).
• Headache and constipation were the most common side effects.

• For patients receiving MEC, palonosetron was more effective than granisetron and ondansetron for the prevention and control of chemotherapy-induced nausea and vomiting (CINV) in the acute phase.
• No significant differences were found in efficacy for patients receiving HEC.

• Limited information about diagnostic information was provided, and no subgroup analysis was conducted for those who were chemotherapy naïve versus those who had received prior emetogenic therapy.
• No description was provided of the actual methods for data collection used, and no description was provided regarding how nausea severity was measured.

Study findings suggest that palonosetron may be more effective for CINV prevention and control with MEC. Palonosetron, as pointed out in this article, is much more expensive than the other medications used, so considering its use in the type of chemotherapy treatment where it appears to be more effective makes sense. Differences in efficacy seen over time suggest that the same drug may have the same efficacy in a patient over the course of therapy. Consideration might be given to studying this issue and the potential of switching drugs at various points.

Investigate omega 3 fatty acids in reducing the incidence and severity of paclitaxel-induced peripheral neuropathy

Patients were randomly assigned to receive omega 3 fatty acid supplements at a dose of 640 mg three times daily, or an identical gelatin placebo capsule. All patients received the intervention throughout treatment and for one month after chemotherapy treatment. Patients were evaluated prior to chemotherapy and one month after completion of chemotherapy. Evaluations were done by a single neurologist.

• N = 57           
• MEAN AGE = 45.9
• FEMALES = 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving four courses of 175 mg/m² paclitaxel for positive node disease.

• SITE: Single site   
• SETTING TYPE: Outpatient  
• LOCATION: Iran

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled, randomized trial

• Total peripheral neuropathy score including sensory symptoms, pin sensibility, tendon reflexes, and nerve conduction studies of sural and peroneal nerves from scores for individual items of 0-4
• Unilateral nerve conduction studies
• Serum concentrations of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

70% of patients receiving omega 3 fatty acid supplements did not develop peripheral neuropathy, compared to 40% in the placebo group (odds ratio = 0.3, .95% CI = 0.10–0.88, p = .029). There was a non-significant trend toward lower severity of symptoms in those receiving omega 3 fatty acids. No significant differences existed between groups in individual nerve conduction study results. Significant differences did exist between groups in serum EPA and DHA concentrations (p < .005) with higher levels in the experimental group. No relationship existed between serum concentrations and peripheral neuropathy scores.

Findings suggest that oral supplementation with omega 3 fatty acids may have a protective effect for development of peripheral neuropathy in patients receiving paclitaxel.

• Small sample < 100
• Measurement/methods were not well described.
• Measurement validity/reliability was questionable.
• Findings were not generalizable.
• Study was underpowered by the authors’ report and calculations.
• The specific grading of findings to calculate the peripheral neuropathy score is not well defined and is not a commonly used and validated scoring approach.
• There was a limited timeframe of follow-up. 
• Findings may not be applicable in patients receiving different neurotoxic drugs.

Findings suggest a neuroprotective effect of omega 3 fatty acid supplementation. These are promising results, which warrant further research in well-powered studies and in the context of other types of neurotoxic chemotherapeutic agents.