The focus of the study was to evaluate the role of glutamate supplementation in preventing paclitaxel-induced peripheral neuropathy.

Patients were randomized to receive daily placebo or 500 mg glutamate supplementation beginning on the first day of chemotherapy. Treatment was continued throughout six cycles of chemotherapy and for an additional three weeks. Patients were assessed for neuropathy with serial electro-diagnostic measurements at baseline and at the end of the study.

The total sample consisted of 43 women with a median age of 59 years (range of 35–80 years) who were diagnosed with gynecologic cancers and were receiving paclitaxel.

The study was conducted in multiple outpatient sites throughout Israel.

Phase of care

• Active antitumor treatment

The study had a double-blind, placebo-controlled randomized trial design.

• Various electro-diagnositic measurements were used to assess nerve conduction and sensory conduction velocity.
• The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) was used for assessment, as was a 0–3 scale to measure change in symptoms.

An indication of peripheral neuropathic toxicity was lower in patients receiving glutamate, but the difference was not statistically significant. However, significantly lower pain levels were noted in the glutamate group (p = 0.011). No differences were found between groups regarding electro-diagnostic measurements.

The study does not provide strong support for the benefit of glutamate in the prevention of peripheral neuropathy in patients receiving paclitaxel. No firm conclusions can be drawn due to study limitations.

• A small sample size (less than 100).
• The questionable validity and reliability of the three-point assessment scale.
• Findings may not be generalizable to patients receiving other chemotherapeutic agents.
• Of the 67 patients randomized, the consort diagram shows a final sample of 43; however, results are only reported for 38 patients. Actual sample and reasons for withdrawal are not well explained.

The findings suggest that glutamate does not prevent peripheral neuropathy during treatment with paclitaxel. Conclusions are limited due to study deficiencies.

To determine if an educational video and/or booklet for people with advanced cancer and pain can improve pain management and quality of life and decrease anxiety, pain, and pain interference

Patients were recruited from multiple oncology and palliative care clinics and were randomly allocated to one of four treatment groups. Patients in group 1 received standard care only. Those in group 2 received standard care plus a booklet. In group 3, patients received standard care plus a video. Group 4 patients received standard care plus a booklet and video. The video depicted patients, a caregiver, and health professionals talking about cancer pain and management. The booklet, published by the New South Wales Cancer Council, contained text and cartoons about pain and its management. Text was written for a reading age of 12 years. Patient assessment was done at baseline and at weeks 2 and 4 after study entry.

• The sample was composed of 140 patients.
• Mean patient age was 69 years.
• Of all patients, 57% were female and 43% were male.
• The sample included a variety of cancer types, with the most frequent being breast and lung cancers. In regard to other patient characteristics, 10% of patients had university-level education, 73% were married, and 77% were in an urban setting. All patients had a pain rating greater than or equal to 2. At baseline, 77% patients were on opioids and 22% were receiving inadequate pain control.

• Multisite
• Outpatient
• Australia

Randomized controlled trial

• Barriers Questionnaire
• Wisconsin Brief Pain Questionnaire
• Pain management index, a composite of the analgesic strength rating and worst-pain rating
• Uniscale for the assessment of global quality of life
• Hospital Anxiety and Depression Scale
• Patients' daily diaries of pain

Barriers were low in all groups at baseline. The barriers scores dropped more in the intervention groups than in the control group, but differences from control or between the other three groups were not significant. There was a significant difference (p < 0.05) in the addiction subscale change in the booklet-only and video-only groups. Authors reported a significantly higher change in average pain (p = 0.0214) between the control and video-and-booklet groups. Authors noted marginal differences in average pain between groups in all other combinations. Reduction in worst pain was significantly greater (p = 0.05) in the video-and-booklet group than in the control group. The size of the differences was small (–1.12). Authors noted no other between-group differences. The presence of a partner increased the effect of any intervention on outcomes (p = 0.004, p < 0.01). According to the pain management index, there was no difference between groups in regard to pain management. Authors observed no difference between groups in regard to anxiety or depression, and they observed no significant change in anxiety or depression. All groups reduced overall consumption of opioids.

In this study a self-administered educational intervention consisting of a booklet and video was associated with a reduction in average pain, worst pain, and fear of addiction.

• The study had a risk of bias due to no blinding.
• The duration of the study was relatively short, four weeks.
• Baseline pain scores of 2 or higher would result in inclusion of patients with only mild pain. Baseline pain intensity data are not provided.
• Authors do not state how much relevant education was included in standard care. Variability among providers could have resulted in substantial differences among subjects.

Findings suggest that standardized education that includes a video and booklet can be helpful in pain management. The effectiveness of the intervention is due, presumably, to greater patient and caregiver involvement in pain management. This study showed that the combination of a booklet and video, along with standard care, was the most effective intervention. The content of each may have reinforced the other. Use of a standardized set of educational materials, such as those used in this study, can be a practical, efficient way to supplement other interventions to manage pain, may be effective in involving patients more directly in pain management, and may help to remove barriers to and misconceptions about pain management.

To determine how women with stage 1 breast cancer-related lymphedema (BCRL) are affected by yoga

• N = 23  
• AVERAGE AGE = 57.6 years (SD = 10.5 years, range = 34–80 years) 
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stage 1 unilateral arm BCRL
• OTHER KEY SAMPLE CHARACTERISTICS: Completed treatment for breast cancer (surgery, radiotherapy, and chemotherapy) at least six months prior to study; aged greater than 18 years; sufficient English literacy to provide informed consent; exclusion criteria included recurrent cancer, infection, complex lymphedema therapy, pregnancy, pacemakers (would affect bioimpedance spectroscopy readings), and severe psychological illness

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Australia

• PHASE OF CARE: Multiple phases of care

Multi-center, randomized, controlled pilot trial using a parallel design with participants allocated to the intervention or control groups on a 1:1 ratio

• Primary outcome measures were arm volume of lymphedema (measured by circumference) and extracellular fluid (measured by bioimpedance spectroscopy).
• Secondary outcome measures were tissue induration (measured by tonometry), levels of sensations, pain, and fatigue (limiting effects measured by a Visual Analog Scale [VAS] and quality of life based on the Lymphoedema Quality of Life Tool [LYMQOL]).

At week 8, the intervention group had a greater decrease in tissue induration in the affected upper arm compared to the control group (p = 0.050) and a greater reduction in the symptom subscale for quality of life (p = 0.038). There was no difference in arm volume of lymphedema or extracellular fluid between groups at week 8. However, at week 12, arm volume increased more for the intervention group than the control group (p = 0.032).

The outcomes of this small pilot trial provided preliminary evidence that an eight-week Satyananda yoga intervention did not exacerbate lymphedema and improved tissue induration ing the affected upper arm as well as quality of life subscale symptoms. However, the fact that these improvements were not maintained at the one-month follow-up when arm volume was increased suggested that yoga needs to be ongoing. This is one of few studies that addresses tissue induration.

• Small sample (< 30)
• Baseline sample/group differences of import
• Other limitations/explanation: Higher body mass index of the participants in the yoga group compared to the control group at baseline, which may have confounded the results

Yoga may reduce tissue induration in the upper arm affected by lymphedema and decrease its associated symptoms. However, additional research trials with longer durations, higher levels of lymphedema, and larger numbers are warranted before definitive conclusions can be made.

To test the effects of yoga on health-related quality of life, life satisfaction, cancer-related fatigue, mindfulness, and spirituality compared to conventional therapeutic exercises during (neo)adjuvant cytotoxic and endocrine therapy in women with stages I–III breast cancer

In a randomized controlled trial (N =119) (with data from 92 used for data analyses), women with breast cancer undergoing oncological treatment were randomly enrolled in a yoga intervention (YI) (n = 45) or a physical exercise intervention (PEI) (n = 47). Measurements were obtained before (t0) and after the intervention (t1), as well as three months after finishing the intervention (t2) using standardized questionnaires.

• N = 92   
• AGE = 40–62 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy, hormonal therapy
• KEY DISEASE CHARACTERISTICS: Breast cancer stage I–III 
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria were (a) acute febrile or psychiatric diseases or (b) regular practice of yoga or experience practicing yoga

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Yoga at the center \"Yoga München GbR\" in Munich, physical exercise at the center \"Gesund. Reha rechts der IsarGmbH\" in Munich, and exercise at home

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial with active control

• Cancer-specific European Organization of Research and Treatment of Cancer Core Quality of life (QLQ-C30) questionnaire for health-related quality of life
• Brief Multidimensional Life Satisfaction Scale
• 15-item Cancer Fatigue Scale (CFS-D)
• 14-item Freiburg Mindfulness Inventory (FMI)
• 15-item version of SpREUK questionnaire for spiritual attitudes and coping with Illness

Statistically significant results were found on most functional scales of the EORTC, which indicated the spontaneous recovery of patients’ quality of life after chemotherapy and/or radiation. The global health, role, and social functioning of patients in both groups improved significantly, yet neither group significantly differed from the other in these variables. Fatigue, dyspnea, appetite loss, constipation, and diarrhea improved in both groups. For “nausea and vomiting” and “pain,” significant changes were observed over time. No difference existed in life satisfaction, cancer-related fatigue, spirituality, and mindfulness between the groups.

High drop out rate may be related to the number of measurements. One of the concerns was that patients in treatment were having difficulty with the exercise and yoga programs thought to be from the side effects of the treatment. Further study focusing on one or two areas would be beneficial.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• The number of lessons varied from 5 to 12, and the time lapse varied from 6 weeks to 25 weeks, which was not considered in the evaluation of the program.

The authors felt that this study may have been accepted by patients post-treatment or by using other forms of yoga. Self-care is becoming more common today, and yoga something you can do for yourself. Further investigation should be conducted to see how effective yoga is for patients with cancer.

To evaluate the efficacy of a single-dose palonosetron plus dexamethasone to control emesis in patients receiving highly emetogenic chemotherapy (HEC) and to measure any reduction of calories consumption related to CINV

At baseline, nutritional evaluation subjective global assessment and assessment of appetite were done. Patients received a single bolus of 250 mcg palonosetron plus a single dose of 20 mg dexamethasone 30 minutes prior to chemotherapy. Subjects recorded emesis, nausea, use of rescue medication, and food intake in daily diaries. Amount of food intake was quantified with the aid of pictures of standard portions.

• The study consisted of 35 patients.
• Mean age was 56 years, with a range of 48–67 years.
• The majority of patients were female (82.9%).
• Diagnoses were solid tumors (soft tissue sarcoma, cervix, bladder, lung, and breast).
• Of those patients receiving HEC, 88.6% were chemotherapy naïve, 28.6% were receiving cisplatin-based regimens, and 71.4% were on ifosfamide-epirubicin regimens.
• At baseline, 82.9% of patients were evaluated as well-nourished.

The study was conducted at a single site.

All patients were in active treatment.

This was a prospective trial (noncomparative, single-arm study).

• Patient diaries were used to record the time of each emesis and each dose of rescue medication, as well as the start and stop times of nausea and food intake. 
• Subjective global assessment of complete response (CR) was no vomiting and no rescue therapy. Complete control was defined as no more than mild nausea.
• Appetite was rated on a visual analog scale (VAS).

• CR was achieved in 85.7% of patients, and CC was achieved in 82.9% of patients in the acute phase.
• During the delayed phase, 82.9% achieved CR and 77.1% achieved CC.
• Overall, 80% achieved CR and 77.1% achieved CC. Even in patients with CC, the presence of residual nausea, although it was rated as mild, significantly decreased calorie intake during the acute and delayed phases (r² = 0.77, p < 0.0001).

Palonosetron was able to prevent both acute and delayed vomiting and nausea in most patients treated with HEC. A strong, significant relationship was found between the presence of nausea and lower caloric intake.

• The sample consisted of fewer than 100 patients.
• No control group was included. This reported provided only preliminary results.
• Aprepitant was not employed as an antiemetic for HEC.
• Patient compliance with the diary was not discussed.
• Caloric intake can only be considered an estimation based on the method of measurement.

• Even mild nausea has a negative effect on caloric intake, and, for those with severe nausea, intake may be diminished drastically.
• Findings support the observation that palonosetron is useful in the prevention of CINV in patients receiving HEC.

To assess the efficacy of a single dose of palonosetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) and guarantee an adequate food intake in patients receiving several cycles of multiple-day-based chemotherapy

Patients with advanced cancer but without a compromised nutritional status (bone mass > 18.5) receiving multiple cycles of multiple days (MD-CT) were treated with 0.25 mg palonosetron over 30 seconds and 20 mg dexamethasone 30 minutes prior to chemotherapy. Patients recorded the number and intensity of emesis episodes, use of rescue medication, and the time and amount of daily food intake including pictures when available.

• The study consisted of 50 patients, none of whom were severly malnourished.
• The median age was 56.8 years.
• The sample was 18% male and 82% female.
• Cancer diagnoses were sarcoma (52%), cervix (34%), bladder (6%), breast (6%), and lung (2%).
• The majority of patients (74%) were chemotherapy naïve.
• Patients had normal renal and liver function, no uncontrolled vomiting, and no intestinal obstruction, peritonitis, serious mucositis, or infections.

This study was conducted at a single site at a hospital in Lecee, Italy.

• Patients were in active treatment.
• This study has application to elderly care.

This was a prospective, uncontrolled trial.

• Patients recorded complete response (CR), defined as no vomiting and no use of rescue medications, in diaries.
• Patients quoted their daily food intake, the time food was consumed, and the amount of each portion eaten. Amount were quantified using pictures of standard portions included in the diary.  
• Diaries had to be completed from day 1 to the end of day 7 (168 hours postchemotherapy).

• During the 6 cycles, CR ranged from 76%–88%.
• Complete Control (CC), defined as no vomiting, no rescue medication, and no more than mild nausea, ranged from 62%–88%.
• Total Control (TC), defined as no vomiting, no rescue medication, and no nausea, ranged from 54%–80%.
• The correlation between severity of nausea and the amount of food intake remained uniform during all cycles.  Patients with CR had a significant higher weekly food intake than those using rescue medication or vomiting.
• Patients who experienced CC and no nausea had a median weekly for intake ranging from 11,102–12,200 kcal compared to patients with CC, but patients with mild nausea had a lower median weekly food intake.

• A single dose of palonosetron and dexamethasone were shown to be effective in prevention of vomiting and nausea in patients receiving multiple day-based chemotherapy and the effectiveness last over six cycles.
• The use of dexamethasone was limited to day one, which may eliminate steroid side effects over multiple cycles.
• A direct correlation was found between severity of nausea and weekly caloric intake. Even mild nausea caused a decrease in kcal consumed between 2,102 to 2,957.  This was maintained across all six cycles.
   

• The sample size was small with fewer than 100 patients.
• Large and randomized studies are needed to assess the role of CINV on food intake in both multiple-day and single-day chemotherapy.  
• Why aprepitant was not used for this highly emetogenic combination of chemotherapy agents is not known as aprepitant is indicated in Oncology Nursing Society (ONS), National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines in combination with a 5-HT₃ and steriod.

A direct correlation exists between mild nausea and significant decrease in food intake. Patients can easily become malnourished. Nurses need to assess closely for nausea, using a Likert-type scale and weight loss and malnutrition.

Palonosetron and dexamethasone can achieve high control of CINV during multiple days and multiple cycles of HEC. Nurses need to use instruments like the subjective global assessment (SGA) used in this study to better identify patients at risk for malnourishment rather than reyling solely on body mass index (BMI).

Patients receiving carboplatin (area under the curve [AUC] 5 mg per minute/ml) and 175 mg/m² paclitaxel were randomly assigned to receive 910 mg/m² IV amifostine 30 minutes prior to carboplatin.

• Patients were diagnosed with stage 2–4 ovarian cancer.
• The study reported on a sample of 187 patients (93 in the amifostine group and 94 in the control group).

The study was conducted between April 1999 and July 2001.

This was a phase III, multicenter, randomized trial.

• Grade 3-4 toxicity was reported.
• The National Cancer Institute (NCI) Common Terminology Criteria (CTC) was used.

A significant difference was found in grade 3-4 mucositis (4.7% in the amifostine group versus 15.4% in the control group, p < 0.0001).

• The study was not double blinded.
• The authors did not indicate clearly how mucositis was measured.
• The data in the article was not clear and specific.

To provide a definitive test of the effectiveness of calcium and magnesium in decreasing oxaliplatin-induced neurotoxicity

Patients randomly were assigned to receive intravenous calcium gluconate and magnesium sulfate at 1 g each in 100 ml of D5W over the course of 30 minutes immediately prior to and after each dose of oxaliplatin. Patients in the control group received a placebo that appeared identical to the study drug with the same administration timing. A third group was administered calcium and magnesium before chemotherapy and a placebo after infusion. Patients with adenocarcinoma of the colon scheduled to receive 12 cycles of FOLFOX chemotherapy including 85 mg/m² oxaliplatin every two weeks were considered for participation. Oxaliplatin dose modifications were not prescribed by the study, but dosage changes or delays were provided as recommendations. Study measures were obtained at each cycle of chemotherapy.

• N = 326 
• MEDIAN AGE = 56 years
• MALES: 48%, FEMALES: 52%
• KEY DISEASE CHARACTERISTICS: All participants were patients with colon cancer receiving either FOLFOX-4 or mFOLFOX-6 treatment.
• OTHER KEY SAMPLE CHARACTERISTICS: 85% Caucasian; majority were diagnosed with stage II disease

• SITE: Multi-site  
• SETTING TYPE: Multiple settings    
• LOCATION: More than 50 sites in the United States

• PHASE OF CARE: Active antitumor treatment

Three-group, double-blinded, placebo-controlled, randomized trial

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) for Chemotherapy-Induced Peripheral Neuropathy (CIPN20)
• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE)

There were no significant differences between the three study arms on the EORTC-QLQ CIPN20 sensory or motor neuropathy scales. There were no significant differences in neurotoxicity assessment using the CTCAE to determine time till grade 2 neurotoxicity or incidence of grade 2 symptoms. A subgroup analysis did not show evidence of benefit in groups according to age, sex, disease stage, or specific FOLFOX regimen. There were no differences in acute or chronic symptoms.

The findings of this study do not support the use of intravenous calcium gluconate and magnesium sulfate to prevent oxaliplatin-induced neuropathy.

This large, well designed trial showed no benefit of the use of a calcium gluconate and magnesium sulfate infusions to prevent peripheral neuropathy in patients receiving FOLFOX. The authors of this study state that as many as 50% of practitioners continue to use this intervention, and resources such as UpToDate suggest consideration of this intervention. Nurses can advocate that calcium gluconate and magnesium sulfate not be used for the prevention of peripheral neuropathy given the lack of evidence for its efficacy. This can save time and expense in treatment for patients receiving this type of chemotherapy. Additional similar research may be needed to examine this treatment's effects in patients at risk for peripheral neuropathy related to other chemotherapeutic agents.

Assess more definitively than previous studies the efficacy and toxicity of various doses of venlafaxine for treatment of hot flashes in the breast cancer survivor

Participants were assigned to placebo (n = 56), or venlafaxine 37.5 mg daily (n = 56), 75 mg daily (n = 55), or 150 mg daily (n = 54).

Patients eligible for this trial were 221 women who had a history of breast cancer or who were concerned about taking estrogen therapy for fear of developing breast cancer.

• Inclusion criteria:
  • Troublesome hot flashes, occurring at least 14 times per week; hot flashes severe enough for the patient to desire therapeutic intervention, and present for at least one month prior to study entry, older than 18 years; life expectancy at least 6 months; and ECOG performance status of 0–1.
  • Anti-estrogens and aromatase inhibitors were allowed if they had been started four weeks prior to study entry and scheduled to continue for the next five weeks.
• Exclusion criteria:
  • Concomitant therapies not allowed: antineoplastic chemotherapy, androgens, estrogens, progestins, antidepressants, clonidine, and combined ergotamine, alkaloids of belladonna, and phenobarbital.   
  • Use of venlafaxine in the past, any antidepressant treatment within the preceding two years, pregnancy, breastfeeding, use of other medications to treat hot flashes within the past two weeks, uncontrolled hypertension.

Double-blind, placebo-controlled, randomized trial

• The primary endpoint:  bivariate construct of average daily hot flash activity: the number of hot flashes and a score combining the number and severity of hot flashes
• Hot flash diaries
• Participants stratified by age (younger than 50 versus older than 50), current tamoxifen use, duration of hot flashes (less than 9 versus more than 9 months) and frequency of hot flashes/day.

It was calculated that a sample size of 50 patients per group would provide 80% power to detect differences in average hot-flash activity of standard deviation (SD) 0–6 (1–2 hot flashes per day, a score of 3 units, or a 21% fall from baseline) with a type 1 error rate of 5%.

Of the 229 patients who joined the study, 191 had data evaluable over the whole study period (50 from the placebo group, 49 from the venlafaxine 37.5 mg group, 43 from the venlafaxine 75 mg group, and 49 from the venlafaxine 150 mg group). After week 4 of treatment, median hot flash scores were reduced from baseline by 27%, 37%, 61%, and 61%, respectively, in the four groups. Frequencies of some side effects (mouth dryness, decreased appetite, nausea, and constipation) were significantly higher in the venlafaxine 75 mg and 150 mg groups than in the placebo group.

The trial suggests that venlafaxine can alleviate hot flashes and that the most appropriate dose for this indication is 75 mg.

Missing data were handled in several ways as a sensitivity analysis of the robustness of the results in relation to the missing data. Less than 10% of possible data were missing, and the results were consistent across a series of analyses by various imputation methods.

The study makes mention that venlafaxine may also be effective against hot flashes in men who have undergone androgen deprivation therapy for prostate cancer.

The study was done to assess the efficacy and short-term toxicity of low-dose megestrol acetate as a treatment for hot flashes in women with breast cancer and in men who had undergone androgen-deprivation therapy for prostate cancer.

Subjects were randomly assigned to receive megestrol 20 mg twice a day for 4 weeks followed by placebo for 4 weeks.or placebo for 4 weeks then megestrol for 4 weeks. Subjects received no medication for the first 7 days.

Of the enrolled subjects, 163 cpmpleted the study. They included women with a history of breast cancer and men who had undergone surgical or medical orchiectomy. All had at least one hot flash per month. Women were stratified according to duration of hot flashes (9 months cut point). Men were stratified by medical or surgical orchiectomy and duration of androgen ablation.

The study was a double-blind, randomized, crossover trial.

Participants kept hot flash diaries,  recording the number and severity of hot flashes each day. They also recorded  appetite changes, fluid retention, and vaginal problems.

During the first 4 week medication period, megestrol was associated with decreased frequency of hot flashes for both men and women. Crossover analysis was not performed because of carryover effects of medication.

There was an insufficient washout period to allow for crossover analysis.