The primary aim of this study was to determine if micafungin is an effective and safe antifungal prophylaxis to be used for neutropenic pediatric patients undergoing chemotherapy treatment or stem cell transplantation treatment for cancer.  

Patient records were reviewed for pediatric oncology patients who received micafungin via IV (3 mg/kg per day) while they were neutropenic from May 2006 to September 2008. A total of 40 children were included in a record review that encompassed 146 patient cycles of chemotherapy.

• The sample consisted of 40 patients.
• Ages ranged from 1–17 years old.
• Key disease characteristics included acute leukemia, non-Hodgkin lymphoma, and solid tumors.
• Although 40 patients were treated prophylactically with micafungin, 39 of them received chemotherapy or stem cell transplantation for their disease. One did not receive either chemotherapy or stem cell transplantation as treatment for their cancer.
   

A single-site setting.

• The phase of care was active treatment
• The application was pediatrics
   

 Retrospective

Development of probable, proven, or suspected invasive fungal infection.

Of the 40 records reviewed, a total of 131 patient cycles were noted for chemotherapy and 15 patient cycles for those undergoing stem cell transplantation. Thirty of 40 patients had successful prevention of invasive fungal infection. Only one patient developed a diagnosed fungal infection, the rest of the failures were suspected fungal infections.

Based on this study, it appears that micafungin may be a safe and effective prophylactic treatment for fungal infection in pediatric patients with cancer. A larger randomized study would be beneficial to prove the success rates in a larger randomized group.

•  The study had a small sample size (less than 100).
•  Invasive fungal infections are more prominent in hematologic malignancies as opposed to solid tumors, thus combining these two populations in a study may skew the results for positive benefit.
   

Micafungin is generally tolerated well with minor side effects and minimal drug-to-drug interactions as opposed to other treatment for fungal prophylaxis. More exclusive, randomized studies are needed to determine if it is appropriate for all patient populations and demographics.

To compare the efficacy of triplet versus doublet antiemetic prophylaxis in patients receiving carboplatin-based chemotherapy

Patients were randomized to triple drug or doublet prophylaxis. Both groups received palonosetron 0.75 mg on day 1 and dexamethasone 8 mg on days 1–3. In addition, those randomized to triple drug therapy received aprepitant 125 mg on day 1 and 80 mg on days 2–3.  Physicians recorded the use of rescue therapy.

• N = 80
• KEY SAMPLE CHARACTERISTICS: Patients were chemotherapy naive.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Open-label, randomized, two-group trial

Complete response rate was defined as no vomiting or rescue therapy.

Aprepitant and control groups showed overall complete response rates of 80.5% and 76.9%, respectively. No significant difference existed between groups. No differences existed in patient reports of nausea.

Doublet antiemetic prophylaxis using palonosetron was as effective as triplet antiemetic treatment for the control of chemotherapy-induced nausea and vomiting (CINV).

• Measurement/methods not well described
• Method of measurement of nausea was not described.  
• Nausea apparently was not considered in the definition of complete control.

The finding suggest that antiemetics with a 5-HT₃ and dexamethasone were as effective as triplet therapy, including an NK₁, for control of CINV in patients receiving carboplatin. The 5-HT₃ used here was palonosetron. A variety of mixed evidence exists regarding the comparative efficacy of doublet versus triplet antiemetics for CINV, as well as the comparative efficacy of dexamethasone-paring regimens and olanzapine-based regimens. Ongoing research and evaluation of comparative effectiveness for various chemotherapy regimens are needed. Multiple factors need to be considered in individualization of antiemetic treatments, and nurses need to evaluate the effectiveness of interventions across cycles to provide the most effective regimen for each patient.

• Interleukin-11 (IL-11) 10 mcg/kg subcutaneous was given daily for two weeks followed by a two-week rest period, then dosing was repeated. After the first two courses (eight weeks), patients who responded continued maintenance therapy with which length of course, rest period, and doses were individualized based on response and side effects. Maintain platelet 150–450.
• Platelet count equation = x 10⁹ /L
• During therapy, CBC with differential and reticulocyte count was done three times per week for the first six weeks and then at least weekly.
• Patients were not transfused if platelets were greater than 10.
• Patient responses had to last at least four weeks while on therapy.
• Median baseline platelet = 12
   

• N = 16
• AGE = 5–84 years 
• MALES: 14, FEMALES: 4
• Two patients were registered in error.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with myelodysplastic syndromes (MDS), aplastic anemia, graft failure, postchemotherapy aplasia, refractory anemia, bone marrow failure after autologous bone marrow transplant. No chemotherapy for two months or disease progression (other than worsening MDS) with platelets less than or equal to 50

• Raise platelet count without significant toxicity.
• Response was doubling of platelets if baseline was 20–50 or tripling if baseline was less than or equal to 20.
• Baseline = median of three untransfused counts within two weeks before starting therapy
   

Six of 16 patients (38%) showed an increase in platelet count greater than 70K, mostly within the first two-week course. Of the six responders, their baseline platelet count was 1–48; none received transfusions. One patient also received granulocyte colony-stimulating factor and erythropoietin; time to response was approximately 20 weeks. Two patients had an abrupt decrease in platelet counts in the two-week rest period between courses. Response duration was 12–30 weeks. Side effects were mild peripheral edema (two patients treated with furosemide 20 mg PO), conjunctival infection, and myalgia; seven patients had no side effects.
 

• Small study size (16)
• Six case studies' responders presented
• Subset of patients with bone marrow failure, mild thrombocytopenia
• Pilot study with review of existing literature
• No control
• Not randomized
   

To evaluate the effect of Sr-89 radionuclide therapy on the quality of life of patients with prostate cancer with painful bone metastases

Sr-89 radionuclide therapy is an established alternative for the palliation of bone pain in prostate cancer. This study is to assess the Sr-89 radionuclide therapy on quality of life (QOL) in patients with prostate cancer and painful bone metastasis.

• N = 13
• AGE = Unknown
• MALES: 100%        
• KEY DISEASE CHARACTERISTICS: Prostate cancer with bone metastases
• OTHER KEY SAMPLE CHARACTERISTICS: Painful bone metastases

• SITE: Single-site 
• SETTING TYPE: Not specified 
• LOCATION: Japan

• PHASE OF CARE: Late-effects and survivorship
• APPLICATIONS: Palliative care

12-week, prospective, single-arm, open-label study

• Japanese version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BM22 and -C30) scale
• Visual Analog Scale (VAS)/Faces Pain Scale (FPS)
• Prostate-specific antigen (PSA) test
• Alkaline phosphate (ALP) test

Three patients reduced their analgesic dosages within three months after Sr-89 treatment. No patients increased their analgesics dosages during the study period. According to the ECOG scale, performance status prior to the Sr-89 treatment was reported by the physician to be 0 or 1 in three patients (23.1%) and 2 or greater in the remaining 10 patients (76.9%). In the QLQ-C30, the mean score for global QOL was 29.9. Overall, there were no significant changes in patients' serum PSA and ALP after Se-89 therapy.

Using the EORTC QLQ-BM22 module, this study showed that Sr-89 therapy improves the comprehensive quality of life of patients with prostate cancer with bone metastases pain. This radionuclide therapy can provide not only reduced pain but also better psychosocial aspects and functional interference in this patient population.

• Small sample (< 30)
• Key sample group differences that could influence results
• Other limitations/explanation: Follow-up period after SR-89 intervention was short (three months). Efficacy if repeated-dose administration were given and the durable effect of Sr-89 were not evaluated.

Treatment with Sr-89 for prostate cancer with painful bone metastases could assist in pain management for this group of patients.

STUDY PURPOSE: To review the evidence for the intraspinal administration of analgesics for refractory cancer-related pain

TOTAL REFERENCES RETRIEVED: 2,672

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A four-point quality scoring system was described.

• FINAL NUMBER STUDIES INCLUDED = 9
• TOTAL PATIENTS INCLUDED IN REVIEW = Not provided
• SAMPLE RANGE ACROSS STUDIES: Not provided
• KEY SAMPLE CHARACTERISTICS: Not provided

PHASE OF CARE: End of life care
 
APPLICATIONS: Palliative care

Four studies compared combinations of opioids and adjuvant drugs to opioids alone. Two studies compared a neuraxial drug bolus with a continuous infusion, one study compared a single drug with a placebo, and two studies compared neuraxial drug administration with comprehensive medical management. Pain relief was reported in all studies comparing opioids alone or in combination with adjuvant drugs. Better analgesic effects were reported with continuous infusion compared to bolus infusion. Sample sizes were small, and the quality of the studies was low.

There was limited evidence regarding neuraxial analgesic administration for intractable pain in patients with cancer.

There were multiple methodologic concerns regarding study design and sample size. There were few studies for each type of study reviewed. Quality issues identified included loss to follow-up, unclear descriptions of setting, and no report of a power calculation. This review did not report sample sizes and graded items such as lack of setting description alone as equivalent to design issues.

There was limited evidence regarding the efficacy of intrathecal analgesic administration compared to other aggressive forms of pain control for patients with refractory pain, and the most effective drugs or drug combinations for this mode of delivery were not clear. Neuraxial treatment requires appropriate resources for safe administration and patient observation. Nurses have an important role to play regarding the selection of patients for safe home-based care delivery and the assessment of patient risks. Additional research comparing the efficacy of various aggressive pain management interventions is needed.

To conduct a randomized, double-blind, placebo-controlled efficacy study evaluating the effects of oral melatonin in improving sleep in patients with cancer experiencing symptoms of insomnia

The investigators randomized participants who consented into group A (melatonin) or group B (placebo) using a fishbowl technique. Melatonin (3 mg) or placebo (multivitamin tablet) was provided by a pharmacist. Tablets were similar in color (light yellow) and shape, and were wrapped in similar envelopes and given to participants. Instructions were to take tablets two hours prior to bedtime every day for 14 days. The Athens Insomnia Scale (AIS) was given by phone or in person on days 1, 7, and 14. Patients and evaluators were blinded to the drug group, and the group was revealed to research staff at the end of the study. Results were compared using a paired t test.

• N = 50    
• MALES: 13% (group A), 13% (group B); FEMALES: 12% (group A),12% (group B)
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Any patients with cancer with sleep complaints were included. No specific exclusion criteria were noted.

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

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

Prospective, randomized, double-blind, placebo-controlled study

The AIS self-assessment psychometric tool for measurement of sleep difficulty is an eight-item scale, and the first five items assess sleep induction, nighttime awakenings, final awakening, total sleep duration, and sleep quality. The remaining three items assess daytime well-being, functional capacity, and sleepiness. Items are scaled using 0–3 ratings, from 0 (no problem) to 3 (no sleep at all). The scale cut-off is 10 to predict outcomes.

Power for a sample size of 25 was verified (90% and alpha = 5%). No significant differences in demographic characteristics of age and sex existed (p > 0.05). Each group had one dropout. The sample was predominantly stage 1 (44% [group A], 40% [group B]) and stage 2 (32% [group A], 36% [group B]), and stage 3–4 was 24% in each group. The majority of subjects (54%) had head and neck cancer (e.g., tongue, larynx) followed by cervix cancer (12%), and 14% had ovarian, gastrointestinal, breast, and sarcomas. Group A had significantly improvements in sleep (p < 0.05) on the AIS at week 1 with intragroup improvements in group A in week 2 (p = 0.00001). The percent change in sleep improvement within group A was significant (p = 0.0001) but not significant in group B (p > 0.05).

The use of 3 mg of melatonin two hours prior to bedtime is an effective nonpharmacological treatment for increasing sleep induction and sleep quality in patients with cancer experiencing insomnia.

• Small sample (< 100)
• Measurement validity/reliability questionable
• Questionable protocol fidelity

Additional large-scale randomized studies are needed to determine efficacy. Melatonin has emerging data to support the nonpharmacological treatment of sleep problems in patients with cancer.

To test the safety and efficacy of treatment with localized radiotherapy and capecitabine for management of painful bone metastases

Women with bone metastases from breast cancer received radiation with 30Gy in 10 fractions to cover all metastatic bone regions, given 5 days per week.  Oral capecitabine at 1400mg/m² was given 5 days per week, concurrently with radiation therapy.  Patients were evaluated weekly during treatment and for every 4 weeks after treatment, for a total of 12 weeks after completion of treatment.

• N = 29  
• MEDIAN AGE = 59 years (range = 35–84 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients had one to three areas of bone metastases from breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Eleven patients were also on bisphosphonates.

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Israel

• PHASE OF CARE: Late-effects and survivorship
• APPLICATIONS: Palliative care 

Phase-II, observational study

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI's CTCEA) version 3
• Pain intensity evaluated on four-point scale 
• Side effects graded on 0–4 scale
• Analgesic consumption graded on a five-point World Health Organization (WHO) scale
• Response graded according to International Bone Metastases Consensus grading

Side effects were mild. The most prevalent were nausea (33%), diarrhea (24%), weakness (21%), and mucositis (10%). The mean pain score decreased from 2.93 to 2.28 after one week (p < .002), to 1.45 after two weeks (p < .0001), and to 1.14 after four weeks (p < .01). Changes in pain scores after four weeks were not significant. Declines in analgesic use were noted during the first four weeks of treatment (p < .02) and were stabilized thereafter. The response rate was 31% at one week and 38% at 12 weeks. There were no differences between patients who did and did not receive bisphosphonates.

Combined radiation therapy with capecitabine was effective for the short-term reduction on pain from bone metastases with relatively mild side effects in the majority of subjects.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Other limitations/explanation: No information was provided regarding pain medications used or pain duration.

Combined radiation therapy and capecitabine may be a promising intervention for the palliation of painful bone metastases. Further research is needed to fully determine its efficacy and toxicity.

To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.

Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.

Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.

Inclusion and exclusion criteria were not specified.

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

• The final number of studies included was 31.
• The sample size across studies was 3,174 participants (range 413–506).
• Participants had various tumor types.
• All participants received radiation therapy (RT).

Patients were undergoing the active antitumor treatment phase of care.

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity. Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects.

Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

• Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.
• Methods for evaluation of the quality of the research were not well described or incorporated into the analysis. 
• Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis. 
• Actual odds ratios or effect sizes from the meta-analysis were not reported. 
• Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article. 
• The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear. 
• The authors stated that they weighted studies by sample size, but this method was not described.

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

To evaluate the effect of the administration of tranexamic acid (TA) upon blood loss and the need for transfusions in patients undergoing head and neck surgery

Patients undergoing supramajor head and neck surgeries were randomized to receive TA (10 mg/kg) or placebo (normal saline). The patients were stratified a priori based upon their anticipated surgical procedure. The attending anesthesiologist, blinded to the drug, administered 100 ml of solution of normal saline with or without TA (10 mg/kg) during 20 minutes postinduction of anesthesia, and, if the surgery was prolonged, every three hours during the surgery. Blood loss was measured during surgery and postoperatively for the first 24 hours. A transfusion trigger was established.

• N = 219   
• AGE = 51.9 years (TA) and 50.67 (placebo)
• MALES: 77%, FEMALES: 23%
• CURRENT TREATMENT:  Other
• KEY DISEASE CHARACTERISTICS: Resectable squamous cell carcinoma oral cavity
• OTHER KEY SAMPLE CHARACTERISTICS: Undergoing surgical resection and reconstructive procedures

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Tertiary referral cancer center in India

PHASE OF CARE: Active antitumor treatment

Randomized, placebo-controlled, double-blind, prospective study

Gravimetry, blood collection in suction bottles, and visual inspection were used to calculate intraoperative blood loss; postoperative blood loss was calculated with a measure of the blood collected in suction bottles during 24 hours.

Differences in intraoperative blood loss between the groups was not significant (p = 0.22); however, the placebo group demonstrated a significantly greater amount of blood loss postoperatively than the TA group (p = 0.009). This difference, however, did not translate to a significant difference between groups in the number of transfusions (p = 0.51).

The administration of TA in patients undergoing head and neck cancer surgery did not decrease intraoperative blood loss or overall blood loss; although it did reduce postoperative bleeding, this did not translate to a reduction in the number of transfusions.

Nurses must assess perioperative blood loss because it places patients at risk for serious complications. An ongoing need to evaluate measures exists to decrease this risk. 

To evaluate the efficacy of low level laser therapy (LLLT) for the treatment of chemotherapy-induced oral mucositis (OM) in pediatric patients undergoing chemotherapy or stem cell transplant

Children and adolescents with cancer receiving chemotherapy or hematopoietic stem cell transplantation (HSCT) who developed grade II OM were included. OM was scored daily by the same investigator. In the experimental group, the treatment was applied to each OM lesion for five consecutive days. The control group received sham treatments to each OM lesion for five consecutive days also.

• The study reported on 14 patients with an age range of 4.8–12.3 years.
• The sample was 19% female and 81% male.
• The sample had three patients diagnosed with solid tumors, 15 patients with lymphoma/leukemia, and three patients undergoing stem cell transplant.

This was a single site, inpatient study conducted in the Pediatric Oncology Unit of the Hospital de Clinicas de Porto Alegre at Federal University of Rio Grande do Sul, Brazil.

The study was a randomized, placebo-controlled trial.

• The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0 was used.
• One examinator assessed mean, standard deviation, and percentiles for age, localization and grade of mucositis, and mucositis severity daily.

No differences were found in grades of mucositis as a function of the LLLT protocol. Mucositis was diagnosed 5.0 to 7.5 days postchemotherapy. On the seventh day after the diagnosis of mucositis, 1 out of 9 patients in the laser group and 9 out of 12 patients in the sham group had grade II or greater OM (p = 0.029). The mean OM duration in the laser group as compared to the sham group was 3.1 days less (p = 0.004).

LLLT can significantly reduce the duration of chemotherapy-induced OM in children.

• The sample size was small with fewer than 30 patients.
• The study did not evaluate pain or functional impairment.

Laser therapy is effective in treatment of mucositis, but it is very high tech and requires special equipment and highly trained personnel.