This was an educational intervention on the side effects of radiation therapy (RT) for prostate cancer; a four-minute followed by an eight-minute tape-recorded message (informational intervention versus standard of care information) was used at treatment 1, and a different message was used at treatment 5. The outcome was the severity of the side effects from RT.

• The sample was comprised of 152 patients receiving RT for curative, localized, prostate cancer.
• Mean age was 70.8 years.
• Of the patients, 96% were Caucasian.
• Of the patients, 13% were in stage A, 66% were in stage B, and 21% were in stage C.

• Eight cancer centers
• Eastern United States

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

A single-item measure of sleep was obtained at week 2 and the end of treatment.

A brief educational intervention is helpful in reducing sleep problems resulting from RT and cancer.

• Baseline symptom severity was not measured.
• Cost is incurred when developing the tape-recorded messages.

No training is required.

To evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) oral spray for the prevention of oral mucositis

Patients were randomly assigned to rhEGF or placebo oral spray. The spray was applied to the entire oral mucosa twice daily from the first day of conditioning chemotherapy until neutrophil recovery. The spray was used six times for each application. Patients were not to eat or drink for 30 minutes after application. The severity of oral mucositis was recorded daily.

• N = 136   
• MEAN AGE = 52 years
• AGE RANGE = 18–65 years
• MALES: 51.5%, FEMALES: 48.5%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients undergoing hematopoietic cell transplantation (HCT). Most had lymphoma or multiple myeloma. Ninety-six percent had autologous HCT.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Republic of Korea

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled, randomized, controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
• Oral Mucositis Daily Questionnaire

No significant difference existed between groups in the incidence of mucositis grade 2 or higher. Subgroup analysis by specific chemotherapy used also did not show any difference. Patients in the study group received less cumulative dose of opioids (p = 0.046) and for a shorter duration (p = 0.036) than those in the control group. No differences between groups in adverse events were reported.

rhEGF oral spray did not reduce the incidence of grade 2 or higher mucositis. This might have a beneficial effect in terms of the reduction of pain associated with oral mucositis.

rhEGF was not shown to have a preventive effect for oral mucositis among patients receiving high-dose chemotherapy prior to HCT. The oral spray examined here may have some positive effect for pain reduction. Additional research is needed to evaluate this potential use.

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.