To determine the effectiveness of palonosetron hydrochloride in preventing nausea and vomiting in patients receiving chemotherapy agents known to cause moderate to severe nausea and vomiting

The study involved administering 0.25 mg palonosetron and a placebo to the experimental group and 3 mg granisetron and a placebo to the control group 30 minutes prior to the administration of moderate to severe emetogenic chemotherapy.

• N = 240
• MEAN AGE = 52.15 years (range = 31–73 years)
• MALES: 26.7%, FEMALES: 73.3%
• KEY DISEASE CHARACTERISTICS: Both the control group and the experimental group had similar percentages of diseases represented: 61% were patients with breast cancer; 21% were patients with non-small cell lung cancer; and the remaining 18% were patients with colorectal, gastric, esophageal, head and neck, and ovarian cancer.    
• OTHER KEY SAMPLE CHARACTERISTICS: About 18% of patients in both groups received moderate emetogenic chemotherapy while about 82% received severely emetogenic chemotherapy. Karnofsky Performance Status scores were ≥ 60; life expectancy was > 3 months; bone marrow function was satisfactory; liver and renal function were normal; ECGs were normal; patients had no side effects from previous treatment except alopecia and nail changes at least three weeks before the last treatment of radiotherapy and chemotherapy; and informed consent was obtained.

• SITE: Multi-site  
• SETTING TYPE: Not specified 
• LOCATION: Eight trial centers in China

• PHASE OF CARE: Active antitumor treatment

Randomized, multi-centered, double-blind, double-dummy, parallel-group, positive-controlled clinical trial

Palonosetron hydrochloride demonstrated better control of delayed vomiting and has a positive preventative effect on delayed nausea and vomiting. There was no difference between granisetron and palonosetron in preventing acute vomiting CR rates, full-course vomiting CR rates, vomiting control time, treatment failure, acute nausea CR rate, or adverse effects.

• Measurement/methods not well described

Palonosetron hydrochloride is an effective 5-HT3 antagonist in preventing delayed nausea and vomiting related to high to moderate emetogenic chemotherapy as compared to another 5-HT3 antagonist, granisetron.

To study the effectiveness of aprepitant as a secondary agent to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer for whom cisplatin-induced nausea and vomiting was poorly controlled by a conventional antiemetic regimen of granisetron and dexamethasone

Stage 1 of the study recruited patients receiving cisplatin-based chemotherapy being actively treated for lung cancer. Patients who experienced vomiting of grade 2 or higher and needed rescue antiemetics during their first cycle of chemotherapy (stage 1) were enrolled in stage 2 of the study. During stage 2, patients had oral aprepitant added on day 1 at 125 mg and on days 2 and 3 at 80 mg daily of subsequent chemotherapy cycles. Patients were asked to keep diaries during the first two chemotherapy cycles.

• N = 25 (stage 2)  
• MEDIAN AGE = 61 years (range = 32–71 years)
• MALES: 4, FEMALES: 21
• KEY DISEASE CHARACTERISTICS: All patients were being actively treated for lung cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were expected to receive at least two cycles of cisplatin-based chemotherapy.

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Beijing, China

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care and palliative care 

Two-stage, prospective observation study

• Demographics and patient characteristics were collected. 
• Patients recorded the number and times they experienced vomiting or retching, the frequency and timing of rescue antiemetic use, the severity of CINV, and adverse events or additional medications taken.
• CINV was monitored for acute (0–24 hours) and delayed (25–120 hours) episodes using the Common Terminology Criteria for Adverse Events version 3 grading scale.
• Outcomes were classified as complete response (CR, no emetic episodes or use of rescue therapy) or complete control (CC, no nausea, emetic episodes, or rescue therapy).

Patients who advanced to stage 2 of the study and who had aprepitant added to subsequent chemotherapy regimens reported significantly less acute and delayed nausea and vomiting compared to their first chemotherapy cycle. During the first cycle of chemotherapy, 18.7% of the 132 patients initially recruited required rescue antiemetics, and 52% required intravenous hydration. Of the 25 patients continuing to stage 2 of the study, none required rescue antiemetics or required intravenous hydration. 64% met the criteria for CR, and 28% met the criteria for CC after round two of chemotherapy.

The findings of this study show that aprepitant was effective in preventing acute and delayed nausea after high-dose, cisplatin-based chemotherapy for patients with lung cancer at a high risk of emesis, anticipatory vomiting, and poor CINV control.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: The study was not blinded, the role of anticipatory nausea and vomiting was not considered, and the effects of the addition of aprepitant was only studied in cycle 2. 

Nursing care would benefit from improved strategies to manage CINV for patients with lung cancer receiving chemotherapy. However, the authors of this study acknowledged that larger randomized, controlled studies are needed before recommendations can be made. The assessment of CINV risk during all cycles of chemotherapy is an important aspect of nursing care and patient advocacy. Outcomes for CINV improve when standardized antiemetic guidelines are followed.

To determine the efficacy of aprepitant on patients in Asian countries receiving highly emetogenic chemotherapy (HEC)

Patients receiving HEC were stratified by gender and randomized to receive either aprepitant or a standard therapy with a placebo. Placebo medications were matched to aprepitant capsules. Data were collected from the time of chemotherapy (0 hours) to six days (120 hours). Patients recorded vomiting episodes, daily nausea, and rescue medications.

• N = 411
• AGE = > 18 years
• MALES: 66 %, FEMALES: 34% 
• KEY DISEASE CHARACTERISTICS: Solid tumors, cisplatin-naïve, and Karnofsky Performance Status Scale score > 60
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded for current illicit drug use; evidence of alcohol abuse; symptomatic primary or metastatic CNS malignancy; administration of chemotherapy of moderate or high emetogenicity within the prior six days; scheduled administration of abdomen/pelvis radiation therapy within one week; scheduled administration of multiple-day chemotherapy with cisplatin in a single cycle or stem cell rescue therapy with cisplatin chemotherapy; active infection or other uncontrolled disease; or concurrent medical conditions precluding Decadron use.

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: China, 16 independent centers

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

A phase III, randomized, double-blind, placebo-controlled, parallel-group trial

Patients self-reported the times and dates of vomiting or retching episode(s), use of rescue therapy, and daily nausea assessments during the first chemotherapy cycle along with Visual Analog Scale (VAS) overall nausea ratings. Patients were contacted on the mornings of days 2–6 to ensure compliance. Functional Living Index-Emesis (FLIE) questionnaire scoring was self-administered early on day 6 directly following completion of final self-reports.

The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior chemotherapy-induced nausea and vomiting prevention and was very well tolerated.

The efficacy and tolerability of aprepitant were studied only for one or two cycles of chemotherapy; further study will be required for multi-cycle treatment. 56.4% of patients in the aprepitant arm used Chinese medicine versus 49% in the control arm.

Aprepitant is well-tolerated and effective in the treatment of CINV in Chinese patients receiving HEC. This is the first study in Chinese chemotherapy patients. Based on nursing knowledge of drug metabolism, this is an important study to assess that aprepitant provides efficacy in this group of chemotherapy patients.

To determine if acupressure affects the postoperative comfort of patients following subtotal gastrectomy

Patients were randomized to acupressure care and control groups. Control patients received usual care. The acupressure group received the intervention for three days. Pressure to the P6 and ST36 acupoints on both sides was applied for 12 minutes using the thumb to apply pressure followed by release, kneading of the area, and release again for each site. The intervention was provided by a trained researcher. Data were obtained at baseline and after the intervention, which began the second day after surgery. Experimental and control patients were placed in different wards in the hospital.

• N = 54
• MEAN AGE = 62.3 years (SD = 15.3 years)
• MALES: 78%, FEMALES: 22%
• KEY DISEASE CHARACTERISTICS: All received subtotal gastric resection for gastric cancer

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Taiwan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care

Randomized, controlled trial

• 11-point Numeric Rating Scale (NRS) for pain
• Rhodes Index of Nausea Vomiting and Retching (RINVR)

There were no significant differences in the trends for pain or postoperative nausea and vomiting between groups.

This study did not show a significant benefit from acupressure for the management of acute pain.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results 
• Measurement/methods not well described 
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: The exact timing and method of obtaining data were not clearly explained, and although it was stated that all patients received the same analgesic regimen, the data showed that some patients received IV PCA, some received epidural analgesia, and some had “other.”

This study did not demonstrate evidence for the efficacy of acupressure for the management of postoperative pain. Additional research would be useful to determine beneficial adjunctive interventions for acute pain management.

To investigate the effects of supervised exercise training on cardiopulmonary function and fatigue in cancer survivors undergoing various clinical treatments.

Patients were divided into four groups based on specific type of treatment:  surgery alone (n = 22); surgery and chemotherapy (n = 30); surgery and radiation (n = 17); and surgery, chemotherapy, and radiation (n = 27). Following comprehensive screening and medical examination, cardiovascular endurance, pulmonary function, and fatigue were assessed. Individualized exercise prescriptions and six-month exercise interventions were developed. Participants attended supervised exercise sessions two to three days per week for six months.

• Ninety-six patients were included in the study.
• This was a convenience sample of breast cancer survivors undergoing various clinical treatments. 
• Age was 57.9 years (standard deviation = 10.4 years). 
• All patients were females with breast cancer. 
• All patients had undergone surgery.
• No significant differences were observed in age, height, or weight between groups.

• Single site
• Outpatient
• Oncology rehabilitation center

This was a pre-/posttest quasiexperimental study.

• Repeated measures ANOVA and ANCOVA were used to compare the effectiveness of the interventions and difference among treatment groups.
• Main variables were systolic and diastolic blood pressure, resting heart rate, forced vital capacity, forced expiratory volume, predicted oxygen consumption, time on treadmill, and fatigue.
• The revised Piper Fatigue Scale (PFS) was used to assess cancer-related fatigue.
• The behavioral fatigue subscale includes six questions and was used to assess the effect of fatigue on school and work, interacting with friends, and the overall interference with activities that are enjoyable.
• The affective fatigue subscale includes five questions to assess the emotional meaning attributed to fatigue.
• The sensory subscale includes five questions to assess mental, physical, and emotional symptoms of fatigue.
• The cognitive and mood fatigue scale consists of six questions.
• The average score on the 22 total questions from the subscales provided the total fatigue score.

Cardiopulmonary function (predicted maximal oxygen consumption and time on treadmill) significantly increased in all groups after exercise training. In addition, resting heart rate and forced vital capacity significantly improved in those undergoing surgery, chemotherapy, and radiation. Psychologically, the exercise intervention resulted in significant reductions in behavioral, affective, sensory, cognitive, mood, and total fatigue scale scores in all three groups who received treatment with surgery. The breast cancer survivors in the surgery alone group showed significant reductions in behavioral, affective, and total fatigue scale scores but not in sensory, cognitive, and mood fatigue scale scores.

The results suggested that moderate-intensity individualized exercise maintains or improves cardiopulmonary function with concomitant reductions in fatigue, regardless of treatment type. Moreover, cancer survivors receiving combination chemotherapy and radiotherapy following surgery appear to benefit to a greater extent as a result of an individualized exercise intervention.

• This was a convenience sample of women from one geographic location.
• The study lacked a control group.

Symptom management recommendations should be given to cancer survivors concerning the effectiveness of exercise throughout the cancer continuum, and the importance of participating in a cancer rehabilitation exercise program should be emphasized.

RESOURCE TYPE: Expert opinion

PHASE OF CARE: Active antitumor treatment

Briefly reviews the management of diarrhea related to checkpoint inhibitor adverse reactions.

Brief literature review of common checkpoint inhibitor adverse and serious adverse events. No evidence quality review was provided.

Patient education is crucial to the early reporting of adverse events that develop in patients after treatment with checkpoint inhibitors. Closely monitor patients with evidence of adverse events. Hospitalization and aggressive patient support may be required for serious adverse events.

• PHASE OF CARE: Multiple phases of care

The AGREE II and Cochrane Risk of Bias tool were used for evaluation of articles. Three practice guidelines and 12 RCTs were evaluated, and 27 supplemental supportive documents were reviewed (e.g., reviews, information summaries, consensus statements, best practice advice), which were not always cancer-focused. Results are summarized briefly with modest overall quality found in the practice guidelines and RCTs. Considerations were made for small samples, short follow-up in effectiveness trials, and lack of details on methods. Formal assessments were not conducted on supplemental articles to fill in missing gaps of knowledge.

The guideline recommends, at minimum, a brief and focused assessment for sleep disturbances in patients with cancer and cancer survivors and provides options for screening tools and self-report assessments. Strategies, algorithms for screening, assessment, and management are provided based on literature, but they also are consensus-driven. The screening should include a short two-step process using standardized tools. The focused assessment then should identify chronicity and severity of the sleep problems (parameters of symptoms of poor sleep included). This includes key questions and a sleep diary for full evaluation. Referrals for noninsomnia-related disorders (e.g., apnea, restless legs syndrome) are prompted within the algorithm. Based on the initial evaluation, nonpharmacologic and pharmacologic interventions are recommended in a step process with care pathways that match the severity of the sleep disturbance (i.e., mild, transient, insomnia syndrome) with three corresponding care pathways. Preventative and supportive educational information is provided for all patients with cancer and cancer survivors that focuses on sleep hygiene and other sleep-promoting strategies. Rationale is provided for each strategy of treatment within this algorithm.

• The guideline addresses sleep disturbances within the context of an insomnia syndrome.
• All other disorders requiring referral are not within the scope of the proposed guidelines.
• Menopause-related sleep disturbances are not addressed.
• The use of the guideline would necessitate training of healthcare providers to fully incorporate into practice. 

A basic and focused screening for sleep problems in patients with cancer is needed, with corresponding treatment and education as pertained to the scope of practice.

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

Guidelines and algorithm developed

• Limited data reviewed.
• Guidelines based on data from 2009
• Implementation and evaluation plans for translation to practice not described

Guidelines developed for clinical practice.

To determine whether modafinil could reduce fatigue related to docetaxel chemotherapy

Patients with metastatic breast or prostate cancer receiving docetaxel chemotherapy and experiencing significant fatigue were randomized to receive modafinil or placebo for 15 days beginning with their third cycle of treatment and repeated for 2–4 subsequent chemotherapy cycles.

• N = 83  
• MEAN AGE = 66.4 years in the modafinil group and 68 years in the placebo group
• MALES: 78%, FEMALES: 22%
• KEY DISEASE CHARACTERISTICS: Primarily Caucasian; metastatic breast/prostate cancer; received at least two cycles of docetaxel; MDASI fatigue score (≥ 4/10); Hgb ≥ 10

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

• PHASE OF CARE: Active anti-tumor treatment

• Phase II randomized, double-blind, placebo-controlled.
• Eligible patients were randomized 2:1 to modafinil or placebo and stratified according to tumor type.

• MD Anderson Symptom Inventory (MDASI)
• Secondary outcomes measures included depression, sleep disturbance, exercise, cognition, and mood states.

The goal was a 10% or greater relative difference between the two treatment groups.

The primary endpoint of reduced fatigue during docetaxel chemotherapy was not statistically different between the two treatment arms.

• Small sample (< 100)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Questionable protocol fidelity
• Other limitations/explanation: Study had to be repowered due to limited recruitment. Unclear how secondary measures were evaluated. Use of dexamethasone premedication.

Features a trend in docetaxel-related fatigue. Effectiveness was not established for the broader cancer-related fatigue treatment.

To determine the short- and long-term effects of bone marrow stromal cells (BMSC) transplantation for breast cancer-related lymphedema and to compare and contrast BMSC transplantation with complex decongestive physiotherapy

Patients in the complex decongestive physiotherapy group underwent manual lymphatic drainage, compression therapy, remedial exercises for arm and shoulder, and deep breathing to promote venous and lymphatic flow. Patients in the BMSC transplant group underwent bone marrow aspiration from the iliac crest, were admitted, and underwent brachial plexus or general anesthesia with range of transplantation being around the axilla, chest wall, and upper arm of the affected extremity. After the intensive phase, all patients were measured for and wore custom garment during waking hours. Patients were interviewed via telephone at 3 months and 12 months after treatment.

• The study sample (N = 50) was comprised of the control group (n = 35) and the intervention group (n = 15).
• Patients on an in-patient unit were enrolled and followed for one year.
• All patients had were female and had underwent breast cancer surgery without radiation five years earlier.

The study took place in a single site in China.

The study used a controlled trial design.

• Pain was assessed on numerical scale from 0–5.
• Volume measurements were performed according to Kuhnke’s Disk Model, measuring the circumferences of the arms at 4 cm intervals beginning at the wrist and ending at the shoulder.
• The volume of edema was calculated as the difference between the affected and unaffected arms; the percentage of edema in the arm was then calculated.
• The percentage of change in the edema arm was calculated by the formula [(VT – VI)/ (VI –VN)] 100, where VT is the post-treatment volume of the edema arm, VI the initial volume of the edema arm, and VN the volume of the normal arm.

Both groups of patients experienced a reduction in pain and lymphedema volume. Patients in the BMSC transplant group had better long-term results. At three months (p = 0.0151) and at 12 months (p = 0.0001) patients in the BMSC group had significantly greater reduction in edema in the affected limb.

Autologous BMSC to treat breast cancer-related upper-extremity lymphedema was effective in the study at one year.

• The study size was small, with less than 100 participants.
• Study cites need for lymphoscintigraphy pre- and post-treatment to evaluate formulation of new lymphatic vessels.
• They study had no random assignment.

The study adds evidence to the effectiveness of complex decongestive physiotherapy in this population, which requires compliance with therapy, education, and support for patients and families.