Evaluate the effect of topical rhEGF spray for the prevention and treatment of OM in patients receiving intensive chemotherapy followed by HSCT for hematoplogic malignancies.

Patients were randomly assigned to spray either 50 µg/ml rhEGF or placebo over entire oral mucosa twice daily. Investigators evaluated adherence by examining residual volume of the spray on a daily basis.

The study was comprised of 58 patients, with a median age of 56.5 years and a range of 18-63.
MALES 53.6%, FEMALES 46.4%
KEY DISEASE CHARACTERISTICS: multiple myeloma, non-Hodgkin lymphoma, ALL, MDS
OTHER KEY SAMPLE CHARACTERISTICS: intensive chemotherapy followed by autologous or allogeneic HSCT

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: South Korea

PHASE OF CARE: Active antitumor treatment

Phase II randomized, double-blind placebo-controlled

NCI Common terminology Criteria for Adverse Events (CTCAE), WHO scale, ECOG, modified Oral Mucositis Daily Questionaire  (OMDQ)

Incidence of NCI grade ≥2 OM 78.6% rhEGF group, 50% in placebo group (p = 0.0496); time to NCI grade 2, 11 days rhEGF; day 10 placebo (p = 0.843), median duration NCI grade ≥2 8.5 days rhEGF and 14.5 days placebo (p = 0.262).

NCI grade ≥3 OM 39.3% in rhEFG group, 32.1% in placebo group (p = 0.577) with median duration eight days rhEGF  versus 16 days placebo group (p = 0.381; QMDQ questionnaire showed reduced limitations in swallowing and drinking in rhEGF group.

rhEGF did not reduce incidence of NCI grade ≥2 OM. Severe OM with WHO grade ≥3 in rhEGF group had shorter duration of TPN use and opioid analgesic use.

Small sample (<100)

OM is debilitating for patients receiving intensive chemotherapy for hematologic malignancies and can lead to resource intensive episodes. To date, IV palifermin is the only available treatment modality for prevention or treatment of OM. Further research is needed to identify other modalities and to continue to explore the effects of rhEGF on prevention and treatment of chemotherapy-induced OM.

To compare the effectiveness of a stellate ganglion block (SGB) versus complete decongestive therapy (CDT) for the treatment of lymphedema in patients with breast cancer

Medical records were used to collect data from patients with secondary lymphedema after treatment for breast cancer. Patients who received an SGB were selected, and a cohort of patients who received CDT matched by age, lymphedema duration, type of surgery, and history of lymph node dissection, which were obtained for comparison. SGBs were done three times, once every two weeks, via an injection of a lidocaine and triamcinolone mixture. Patients in the SGB group also did self-massage. In the CDT group, lymphedema measurements were taken after two weeks. In the SGB group, measurements were taken two weeks after each block was performed.

• N = 60  
• MEAN AGE = 58.2 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Only unlilateral arm lymphedema cases were included. The average duration of lymphedema was 17.5 months, and the time range since mastectomy was 30–35 months. 
• OTHER KEY SAMPLE CHARACTERISTICS: All patients had chemotherapy, and most also had radiotherapy.

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: South Korea

• PHASE OF CARE: Active antitumor treatment

Retrospective cohort comparison

• Arm circumference measurements

The effects of treatments on forearm measurement were 1.03 cm and 1.26 cm for CDT and SGB, respectively. This difference was not significant. Upper arm measurements were 0.94 cm after CDT and 1.81 cm after SGB (p < 0.01). SGB-related changes were only seen after the third block. In both groups, there was a significant reduction in arm circumference after the intervention (p < 0.001).

Both CDT and serial SGBs were associated with reductions in arm lymphedema. The findings of this study showed greater reductions on average with SGBs.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

This study suggests that SGBs may be an effective alternative treatment for arm lymphedema after surgery for breast cancer. Additional research in this area is needed.

The aim of the relaxation breathing exercise (RBE) intervention was to improve the function of immune cells.

Before the intervention, a 30-minute recorded audiotape of RBE was given to the patients. RBE consisted of a three-step sequence, which combined relaxation breath and yoga-like positioning exercises:

1. Preliminary exercises for 10 minutes
2. Relaxation breathing for 10 minutes
3. Finish exercises for 10 minutes.

The RBE intervention was provided to patients by one of the researchers at 4:00 pm every day for six weeks in the hospital. RBE was to be practiced in a supine position on a bed. For the control group, routine care (granulocyte-colony stimulating factor [G-CSF] injection and aseptic care) were given. Fatigue was measured at baseline and as posttest data in both groups.

• The sample was comprised of 35 patients with leukemia or severe aplastic anemia.
• Mean age was 32.9 years and 34.3 years for the exercise and control groups, respectively (range 20–48 years).
• Most patients were married, and men and women were equally distributed in the exercise and control groups.
• Patients were excluded if they were taking medication to relieve anxiety or depression.

Patients were recruited from an inpatient hematopoietic stem cell transplant unit (single site).

Patients were undergoing the active treatment phase of care.

The study was a randomized, pre-/posttest control group clinical trial:

1. RBE group (n = 18)
2. Control group (n = 17).

Revised Piper Fatigue Scale (PFS)

The RBE intervention resulted in a significant decline in mean fatigue scores for the RBE group (mean change = –3.2) compared to the control group (mean change = +0.3) (p = 0.0001). The RBE group had greater decreases in the behavioral/severity, affective meaning, sensory, and cognitive mood dimension compared to the control group. In pretest scores, fatigue scores were highest in the sensory dimension, followed by cognitive/mood and behavioral/severity in the RBE group. Sensory dimension was also the highest in the control group. At pretest, there were no significant differences in fatigue scores between groups.

• The intervention was over a short period of time; therefore, the long-term effects of relaxation breathing exercises are unknown.
• The study had a small sample size.

Patients were randomly assigned to either the placebo control group or the intervention group after being stratified by work status and whether they were receiving hormone treatment. Patients in both the intervention and placebo control groups listened to brief tape-recorded messages in the clinic before their first and fifth radiation therapy treatments. The lengths of the audio-only tapes were four and eight minutes for each of these two treatments. A member of the research staff stayed with each patient while the tape recordings were played. The tape-recorded messages for the placebo control group contained general and global information that was generally available to all patients receiving radiation therapy, including resources available to them in the treatment setting. The messages also included self-care instructions to help patients control or lessen side effects. For the intervention group, the tapes were designed to deliver specific, descriptive, sensory messages regarding radiation therapy procedures and related information based on self-regulation theory, in addition to the same self-care instruction, as was given to the comparison group. The information was developed from descriptive data collected from men undergoing radiation therapy for prostate cancer and was tailored to match the standard practices of the radiation facility of each participating institution.

• In total, 152 men receiving radiation therapy as curative treatment for localized prostate cancer were included.
• Mean age was 70.8 years (range 44–85).
• Most patients were married (86%), retired (76%), Caucasian (96%), and had at least a high school education (88%).
• The distribution of disease stage was 13% with stage A, 66% with stage B, and 21% with stage C disease.
• Most patients (92%) did not receive hormone therapy.
• Thirty-four patients were employed.

Radiation oncology facility of one of eight cancer centers

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with an attentional control group.

Profile of Mood States (POMS)

Patients who received the informational intervention containing detailed information concerning radiation therapy and potential side effects reported less severe fatigue at the second radiation treatment and at the conclusion of treatment than patients who received only general information.

• It was unclear whether group allocation was concealed from the investigators.
• Longer follow-up is indicated because fatigue might be expected to continue to increase in the weeks following the conclusion of radiation therapy.
• There were initial costs to develop the audiotapes.

To compare palonosetron-based and first generation 5-HT3 receptor antagonist-based triple drug therapies on chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiday highly emetogenic chemotherapy (HEC)

The study was open to patients who received multiday HEC. Patients were divided into two groups according to the triple-drug antiemetic therapy prescribed by the treating physician. The experimental group received 0.25 mg fixed-dose palonosetron 30 minutes prior to chemotherapy. The control group received any first-generation 5-HT3 receptor antagonist including ondansetron, granisetron, dolasetron, and ramosetron. The first-generation drug was administered at the recommended dose prior to chemotherapy either via IV or orally. All patients received 125 mg oral aprepitant and 12 mg oral dexamethasone on day 1 prior to chemotherapy and received 80 mg oral aprepitant and 8 mg oral or IV dexamethasone on both days 2 and 3 prior to chemotherapy. Either 10 mg IV metoclopramide or 1 mg lorazepam was used for breakthrough CINV. Baseline data and CINV-related data were collected from electronic medical records for 120 hours after chemotherapy began.

• N = 115  
• MEAN AGE = 54.39 years
• MALES: 63.5%, FEMALES: 36.5%
• KEY DISEASE CHARACTERISTICS: 80.9% of patients had solid tumors
• OTHER KEY SAMPLE CHARACTERISTICS: 88.7% of patients received cisplatin-based therapy

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: South Korea

• PHASE OF CARE: Active antitumor treatment

Retrospective analysis

• Number of emetic episodes
• Time to first emetic episode
• Severity of nausea (categorized by patient’s physician)
• Use of rescue medication
• Number of days with rescue medications
• Time to first administration of rescue medication

There was no statistically significant difference in complete response rates between the two study groups in any phase (acute phase 0–24 hours [p = .877]; overlap phase 24–120 hours [p = .997]; overall phase 0–120 hours [p = .723]). There was no statistically significant difference in the number of patients who achieved complete control in any phase of the study (acute phase 0–24 hours [p = .862]; overlap phase 24–120 hours [p = .838]; overall phase 0–120 hours [p = .828]). Within this sample, more women than men experienced acute nausea (p = .040) and vomiting (p = .046).

There was no significant difference in the complete response between the two groups in the acute phase (0–24 hours), overlap phase (24–120 hours), or overall phase (0–120 hours).

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

Palonosetron-based triple antiemetic therapy is not more effective than triple therapies that use older 5-HT3 receptor antagonists as part of the regimen. Both regimens should be considered when choosing a triple-drug therapy combination for the prevention and management of CINV.

To determine the efficacy (as measured by complete response [CR]) of the granisetron transdermal system (GTS) compared to IV and oral granisetron in managing chemotherapy-induced nausea and vomiting (CINV) in Korean patients receiving moderately emetogenic chemotherapy (MEC)

Adult patients with cancer (aged 20 years or greater) assigned to receive the first cycle of a MEC regimen (according to National Comprehensive Cancer Network guidelines) in three hospitals in Korea were eligible to participate. Patients were randomly assigned to receive either GTS or IV/PO granisetron. In the GTS group, patches were applied 24–48 hours prior to chemotherapy and left in place for four days. In the control group, patients received 3 mg IV granisetron day 1 and 1 mg of oral granisetron every 12 hours on days 2 and 3. All patients received 10 mg of IV decadron on day 1. Patients recorded daily in diaries and rated nausea and vomiting on four- and five-point scales. Quality of life was assessed using the Functional Living Index-Emesis (FLI-E). The primary endpoint was the percentage of patients achieving complete response from beginning of chemotherapy until after the final administration from the PPS group.

• N = 263
• MEDIAN AGE = 56 years
• MALES: 62.4%, FEMALES: 37.6%
• KEY DISEASE CHARACTERISTICS: 97.9% had gastrointestinal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group score ≤ 2; life expectancy of ≥ 3 months; receiving a three-day course of MEC; 77% receiving either FOLFOX or FOLFIRI; exclusion criteria included all other sources of nausea and vomiting including opioids for pain

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: Three hospitals in South Korea

• PHASE OF CARE: Active antitumor treatment

Randomized, active controlled, open-label, prospective, multicenter trial

The primary efficacy endpoint was CR for the entire regimen, and the secondary endpoint was daily complete response. Patients kept daily diaries, and the Functional Living Index-Emesis (FLI-E) was used to measure patient satisfaction. Efficacy was assessed using a noninferiority model with a noninferiority margin of 15% as determined by a previous comparison research of serotonin antagonists.

GTS showed noninferior efficacy to intravenous and oral granisetron. The safety, tolerability, and FLI-E scores of the GTS were comparable to those of the control group. GTS offers a convenient alternative option for relieving CINV in patients receiving MEC.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Findings not generalizable

Because the results of this trial suggest GTS is no-inferior to IV or oral granisetron it offers a convenient alternative for relieving CINV in patients receiving MEC. GTS should be considered for patients with gastrointestinal malignancies who are at an even greater risk of having issues with nausea, abdominal pain, or malabsorption, especially male patients.

To evaluate the effectiveness of mirtazapine for nausea and insomnia in patients with cancer with depression

Assessments were conducted at baseline and on days 1, 3, 5, 7, 14, and 28 by trained psychiatrists in an outpatient clinic. In addition, side effects were assessed with each visit. This was a four-week study.

• The study consisted of 28 patients with cancer with depression.
• Patients were eligible if they had a malignant cancer with nausea or insomnia and met the Diagnostic and Statistical Manual for Mental Disorders VI diagnostic criteria for major depression.
• Participants were excluded if they were taking other antidepressants to control depressive symptoms.

Participants were recruited from a university cancer center in Korea.

This was a prospective, open-label study.

The following measurement tools were used.

• Clinical Global Impression Scale for Nausea and Vomiting
• Chonnam National University Hospital-Leeds Sleep Evaluation Questionnaire
• Montgomery-Asberg Depression Rating Scale (MADRS)
• Euro-Qol (EQ-5D) Short Form Health Survey (SF-36)

• Most patients (93%) experienced significantly improved nausea from day 1 without increasing dosages or adding antiemetics.
• The subjects were divided into two groups: patients undergoing chemotherapy (n = 11) and those not undergoing chemotherapy (n = 17). The improvement was sustained in both groups; however, changes in nausea were greater for patients receiving chemotherapy.
• Total night sleep time improved from days 1-5.
• A reduction in scores for pain and anxiety were found on the MADRS and the VAS of EQ-5D.

Mirtazapine rapidly improved nausea, sleep disturbance, pain, depression, and quality of life for patients with cancer.

• A possible placebo effect may have influenced the results.
• This was not a controlled trial.
• The sample size was small and a large number of variables existed.
• The physical status, symptom of depression, frequency and length of assessments, and outpatient clinic visits for the assessment may have contributed to a high participant dropout rate.

An educated treatment group received the intervention consisting of a 30-minute tape and researcher on relaxation breathing exercise (RBE). The intervention was given every day at 4 pm for six weeks during hospitalization for allogeneic stem cell transplantation.

• Of 42 randomized patients, 35 completed the study (18 in RBE group, 17 in control group).
• Patients were excluded if they were taking medications for anxiety.

A randomized controlled trial design was used.

• Measurements: pre/post-test
• State-Trait Anxiety Inventory (STAI): Only state anxiety was measured.

Patients in the RBE group had a mean decrease of 13.3 points in anxiety (p < 0.05).

RBE could be an effective nursing intervention to reduce anxiety in hospitalized patients undergoing allogeneic stem cell transplantation.

The study had a small sample size.

To evaluate whether standardized educational tools, with or without telemonitoring, can improve the pain levels, pain interference, anxiety, depression, distress, performance, and quality of life of outpatients with cancer who have advanced tumors

Patients were randomized to receive either standard pain education plus telemonitoring or standard education alone. A nurse practitioner (NP) performed telemonitoring of pain every day for one week. The NP telephoned the patients and asked for average visual analog scale (VAS) pain score and worst VAS pain score in the last 24 hours. This provided patients with the opportunity to assess the severity of pain themselves. Using the National Comprehensive Cancer Care Network (NCCN) guidelines for pain management, the NP advised patients whether to increase or decrease medication. The NP was trained in pain management but had no specific training for other psychosocial interventions. Standard education included a video and booklet with individual coaching, to correct misconceptions, and an outline of decision making for pain control. Outcomes were measured at one week, and average pain was measured at two months.

• The study reported on a sample of 108 patients.
• Mean patient age was 59.8 years.
• The sample was 67.6% male and 32.4% female.
• The sample included patients with stage IV solid tumors (breast, gastrointestinal, genitourinary, lung, head and neck, and other).
• Most patients had been prescribed opioid analgesics.

• Single site
• Outpatient
• Seoul, Republic of Korea

• Patients were undergoing the end-of-life phase of care.
• The study has clinical applicability for elder care and palliative care.

A randomized controlled trial design was used.

• Brief Pain Inventory (BPI)
• Hospital Anxiety and Depression Scale (HADS)
• Distress Thermometer
• European Organization for Research and Treatment of Cancer quality of life questionnaire
• Karnofsky Performance Status score

Pain intensity, for all patients, had significantly improved at one week, including worst pain (7.3–5.7, p < 0.01) and average pain (4.6–3.8, p < 0.01). Additionally, anxiety (HADS score ≥ 11, 75%–56%, p < 0.01), depression (HADS score ≥ 11, 73%–51%, p < 0.01), quality of life (fatigue and insomnia), and Karnofsky score (32–66, p < 0.01) were significantly improved at one week. However, the level of distress did not improve. The study revealed no significant differences between groups in these areas.

Standardized pain education delivered by a nursing specialist is an efficient means of improving not only pain but also anxiety, depression, performance, and quality of life. This study did not show that the addition of telemonitoring substantially improved pain management in the outpatient setting.

• The study had risk of bias due to the lack of an appropriate attentional control condition.
• A one-week study may be too short to show significant improvement in pain outcomes.
• To extend this study, researchers should conduct a baseline screening with multiple variable assessments in addition to the Karnofsky score.

Findings show that comprehensive pain education was associated with short-term reduction in pain, anxiety, and depression scores. The addition of telemonitoring follow-up for pain management did not result in a significant difference in these scores; however, the follow-up period  was only one week. Longer-term studies of the effects of monitoring via telephone and other technologies, for the purpose of improved symptom management, may be helpful in identifying effective methods of improving symptom control in outpatient settings.

To evaluate the effectiveness of prophylactic itraconazole in preventing fungal infections in pediatric autologous hematopoietic stem cell transplant (HSCT) recipients.

Patients with high-risk solid tumors undergoing autologous HSCT were divided into prophylaxis and empirical treatment groups to evaluate the effectiveness of itraconazole prophylaxis in pediatric autologous HSCT.  High-risk solid tumors included high-risk neuroblastoma, high-risk embryonal brain tumor, bilateral advanced retinoblastoma, and relapsed solid tumors. Patients were then randomized to prophylaxis or empirical treatment groups.  In the prophylactic group, itraconazole was given intravenously at 2.5 mg/kg/dose twice daily for the first two days followed by 2.5 mg/kg/dose once daily for the duration of treatment after the absolute neutrophil count (ANC) fell below 0.5x10⁹/L, even in the absence of fever.  In the empirical treatment group, a placebo was given once the ANC fell below 0.5x10⁹/L after the initiation of high-dose chemotherapy, and itraconazole was started only when a fever persisted for more than three days or if fever recurred despite the use of first-line antibiotics (in this case, cefepime) for more than three days. All antibiotics, including itraconazole, were discontinued after three consecutive days of no significant fever (<37.5°C), no evidence of documented or clinically suspected infection, and an ANC greater than 0.5x10⁹/L.  For microbiologically documented infections, the antibiotic regimen was altered as needed.

• Fifty-five patients who underwent 90 autologous HSCTs were included.  
• Median age was 49 months (range 15–300) in the prophylactic group and 46 months (range 17–302) in the empirical group.
• The numbers and percentages of males and females were not reported.
• Key disease characteristics were neuroblastoma (38.1% in the prophylactic group, 41.9% in the empirical group), brain tumor (40.5% in the prophylactic group, 44.2% in the empirical group), retinoblastoma (9.5% in the prophylactic group, 9.3% in the empirical group), Wilms' tumor (4.8% in the prophylactic group, 4.7% in the empirical group), osteoscarcoma (4.8% in the prophylactic group, 0 patients in the empirical group), and primitive neuroectodermal tumor (1 patient in the prophylactic group, 0 patients in the empirical group).  Patients were newly diagnosed (83.3% in the prophylactic group, 83.7% in the empirical group) or had relapsed (16.7% in the prophylactic group, 16.3% in the empirical group).
• Patients were either receiving their first HSCT (47.6% in the prophylactic group, 53.5% in the empirical group) or their second HSCT (52.4% in the prophylactic group, 46.5% in the empirical group). Time to ANC greater than 0.5x10⁹/L was 10 days (range 8–15) in the prophylactic group and 9 days (range 7–16) in the empirical group; duration of ANC of less than 0.5x10⁹/L was 11 days (range 6–22) in the prophylactic group and 10 days (range 5–18) in the empirical group.
   

• Single site  
• Inpatient
• Pediatric Stem Cell Transplantation Unit of Samsung Medical Center

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

This was a prospective double-blind, randomized study.

• Total duration of fever    
• Duration of antibiotic treatment
   

No cases of proven, probable, or possible invasive fungal infection occurred in either group.  The duration of fever higher than 38ºC was significantly shorter in the prophylaxis group than in the empirical group.  The number of patients who had fever for more than seven days, which was the duration of antibiotic use, and the number of patients who needed additional second-line antibiotic treatment, were lower in the prophylactic group than in the empirical group.  There was no difference in the development of serious adverse events between the prophylaxis group and the empirical treatment group.  The expected benefit of prophylaxis in patients with severe mucositis did not seem to be relevant because there was a reduced duration of fever regardless of the severity of mucositis.

Although there were no infections in the prophylactic group, this was not different than the results in the empirical group.  There was no statistically significant finding to come from this study.  There were some promising findings, such as decreased need for second-line antibiotics and decreased duration of fever, but a larger study would be necessary to prove that these are relevant findings because the power was not high enough in this study.  This was a limited population, and the findings may not be generalizable to adult patients undergoing HSCT.

•  Small sample (<100)
•  Drug levels of itraconazole were not measured.
   

This article educated about fungal infections and the need for antibiotics, as well as neutropenia and the expected adverse effects of transplant.  There are no specific nursing implications for this study because there were no significant findings.