Participants were randomly assigned to receive either 3 mg oral budesonide three times per day for a total of eight weeks during two cycles of irinotecan or a placebo. Rescue medication was given at an initial dosage of 4 mg loperamide followed by 2 mg every two hours until free of diarrhea for 12 hours.

The study reported on 56 patients with advanced colorectal cancer receiving 125 mg/m² irinotecan once per week.

This was a prospective, double-blind, placebo-controlled, multicenter, randomized phase III trial for prevention of diarrhea.

Patients recorded presence of diarrhea (defined as more than four stools per day), duration of diarrhea, and use of loperamide in patient diaries.

Diarrhea could be prevented in 58.3% of the budesonide-treated patients compared to 38.5% of the patients receiving the placebo (p = 0.257).

Budesonide provided superior prevention of diarrhea compared to placebo in the first cycle. However, the trial failed to show that budesonide provided a statistically significant benefit in preventing irinotecan-induced diarrhea.

• The sample size was small.
• Therapeutic administration might be more efficacious than prophylactic administration.

In a previous study (Lenfers, 1999), budesonide was found to be effective in treatment chemotherapy-induced diarrhea in patients who had treatment failure with loperamide. Budesonide also has been proposed as a therapeutic approach for inflamed bowel. However, this study did not support that finding. Further research is warranted.

To compare the safety and efficacy of oral and intravenous palonosetron when used to prevent chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based chemotherapy

On day 1 of chemotherapy, subjects were given either 0.50 mg oral palonosetron or 0.25 mg IV palonosetron in addition to oral dexamethasone at 20 mg on day 1 followed by 8 mg orally as needed on days 2–4. The use of rescue medication was considered a treatment failure. Metoclopramide tablets were available, the use of other 5HT3s was discouraged, and the use of palonosetron was not allowed. 

• N = 738  
• MEAN AGE = 58 years
• MALES: 59%, FEMALES: 41%
• KEY DISEASE CHARACTERISTICS: 87% white and 13% Asian; primary cancer diagnoses were 47% lung, 23% other, 18% head and neck, and 7% gastric; 51% had primary disease; 46% had metastatic disease; 3% local recurrence
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria included: age ≥ 18 years old; histologically or cytologically confirmed malignant solid tumor; Eastern Cooperative Oncology Group performance status of 0–2; and adequate hepatic, renal, and hematologic function. Exclusion criteria included the inability to receive moderately or highly emetogenic chemotherapy on days 2–5 following cisplatin or radiation therapy to the abdomen or pelvis within one week prior to day 1.

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: United States, Latin America, Europe, Asia, and the Commonwealth of Independent States

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, double-blinded, double-dummy, parallel-group, stratified study

• Impact on quality of life was measured by the modified Function Living Index-Emesis (FLIE).
• Safety assessments included a physical examination, vital signs, electrocardiogram, laboratory analysis, and reports of adverse events.

The acute phase complete response (CR) rate was 89% in the oral palonosetron group and 86% in the IV group. The CR rate in the delayed phase was 76% for oral versus 75% for IV palonosetron. There was no difference in the percentage of patients with no emesis in the delayed (79% oral versus 78% IV) and overall phases (76% oral versus 73% IV). There was no overall statistical difference in nausea and the use of rescue medication between the oral and IV groups in the acute, delayed, and overall study phases. Study drug treatment-emergent adverse events were rare (3.2% oral versus 6.5% IV).

IV palonosetron was not superior to oral palonosetron in preventing CINV from platinum-based highly emetogenic chemotherapy. Both routes had similar efficacy in the acute, delayed, and overall phases. 

Oral 0.50 mg and IV 0.25 mg palonosetron were effective in preventing CINV in highly emetogenic chemotherapy regimens containing cisplatin without increasing the risk of adverse events. The availability of oral antiemetics provides opportunities to decrease the amount of time patients spend in the clinic receiving IV premedications. This may decrease the cost of treatment because of the decrease in chair time.

• Cyproheptadine 8 mg by mouth three times daily versus placebo
• Patients stratified for
  • Primary disease site: lung, gastrointestinal, or other
  • Chemotherapy: CDDP or non-CDDP
  • Amount of RT: whole or upper abdomen

• N = 293 evaluable patients (143 cyproheptadine, 150 placebo)
• KEY DISEASE CHARACTERISTICS: The three groups entered had the following key disease characteristics.

1. Advanced malignant disease with no definite planned cytotoxic therapy with weight loss of five pounds over two months and intake less than 20 calories/kg
2. Same as 1 but patients receiving chemo or immunotherapy
3. Same as 1 but receiving upper abdominal or whole abdominal RT with planned dose greater than 2500 cGy

• EXCLUSION CRITERIA: Tube feeding or parenteral nutrition; life expectancy less than six weeks; ascites, pedal edema; mechanical obstruction; brain tumors; glaucoma; urinary hesitancy; concomitant treatment with steroids, progestational agents, and MAOI inhibitors

• Randomized, placebo-controlled, double-blinded clinical trial

• Percentage of weight change from baseline values (Patients’ weights were monitored monthly by HCP, and patients were asked to weigh themselves weekly at home.)
• Patient appetite questionnaire
• Food intake questionnaire
• Perceived drug benefits and toxicities (e.g., lethargy, sedation, nausea, dry mouth)

• Appetite improved
  • 64% of cyproheptadine
  • 50% of placebo
  • P = 0.02
• Average maximum weight gain
  • Cyproheptadine: 0.9 pounds
  • Placebo: 0.5 pounds
  • P = 0.78
• Average weight loss
  • Cyproheptadine: 4.5 pounds
  • Placebo: 4.9 pounds
  • P = 0.72
• Toxicities: Lethargy, dizziness, dry mouth

Cyproheptadine in patients with advanced malignant disease showed mild appetite enhancement but no significant weight enhancing effect.

• Patients remained in the study for a short time. The median time in the study was 34 days with cyproheptadine and 39 days with placebo. Only 25% of the patients entered still were participating in it after three months. 
• The intervention was done late in the disease trajectory.

The study group used oral cryotherapy, via ice cubes “at a size that could be moved easily in the mouth and whose corners have been smoothed in order that they will not cause irritation in the mouth,\" beginning five minutes before chemotherapy initiation and maintained use during IV infusions of etoposide, platinol, mitomycin, and vinblastin. For random allocation, patients were assigned to the study group or a control group in sets of five.

• The study involved 60 patients, with 30 in the study group and 30 in the control group.
• The majority of patients (66.7%) were older than 60 years of age.
• Patients were excluded from the study if they
  • Had previously undergone their first chemotherapy.
  • Were not receiving combined courses.
  • Were given chemotherapy agents other than etoposide, platinol, mitomycin, or vinblastine.
  • Had malignancy in the oral cavity. Five of the patients had oral infection findings in the oral cavity prior to study.
• Cancer diagnoses were epidermoid (43.3%), small cell (28.3%), adenocarcinoma (11.7%), and mesothelioma (16.7%).
• Chemotherapy regimens were one-day etoposide-platinol (43.3%); three successive days of etoposide-platinol (28.3%); one-day mitomycin, vinblastin, platinol (11.7%); and one-day mitomycin-platinol (16.7%).

The study was conducted at a respiratory disease clinic in Turkey from August 2000 to May 2001.

• A data collection form and patient-judged 0–4 mucositis grading scale were used on days 1–21. A 0–4 physician-judged mucositis grading scale was used on day 21 for patients receiving single-day protocols and on days 2, 3, and 21 for patients receiving three-day protocols. The mucositis grading scales were based on the Mucositis Grading System of the World Health Organization (WHO).
• An oral pH measurement scale was used before and after single-day chemotherapy regimens, before and after each day of chemotherapy for multiday chemotherapy regimens, and on day 21 for all subjects.

• The study group experienced a decrease in the severity and duration of mucositis and in oral pH values.
• Rates of mucositis were lower in the study group.
  • Patient-judged mucositis was 36.7% in the study group and 90.0% in the control group (p < 0.05).
  • Physician-judged mucositis was 10.0% in the study group and 50.0% in the control group (p < 0.05).

• The sample size was small.
• Physicians only assessed mucositis on days 1, 2, 3, and 21, but not during the entire chemotherapy course.
• Application to other chemotherapy agents is not known.

To determine efficacy of back massage on fatigue and anxiety in patients receiving chemotherapy

Before chemotherapy infusions were started, patients completed study data collection in face-to-face interviews. During chemotherapy administrations, patients in the intervention group received a back massage for 15 minutes before the infusions and between 25–40 minutes of each one-hour period of chemotherapy administration. Data collection was repeated immediately after the massage intervention, and patients were interviewed by phone 24 hours after the chemotherapy treatment for the completion of postintervention data collection. Patients were not randomly assigned to treatment and control groups.

• N = 40  
• MEAN AGE = 49.94 years (SD = 11.31 years)
• MALES: 45% (intervention group); 50% (control group), FEMALES: 55% (intervention group); 50% (control group)
• KEY DISEASE CHARACTERISTICS: Breast and lung cancers were the most frequent diagnoses.
• OTHER KEY SAMPLE CHARACTERISTICS: All patients were receiving single-day chemotherapy. Massage interventions were done during the third or fourth chemotherapy treatment. None of the patients were actively working at the time.

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

• PHASE OF CARE: Active antitumor treatment

Quasi-experimental, cross-sectional cohort study

• Spielberger State-Trait Anxiety Inventory (STAI)
• Brief Fatigue Inventory (BFI)

Fatigue scores were significantly different between groups at baseline and higher in the control group the day after chemotherapy. There were no significant differences between groups in the change of fatigue pre- and postintervention. Mean anxiety scores in the control group increased after chemotherapy while those in the intervention group declined. Differences between groups were not statistically significant.

Findings provide limited evidence that back massages may be helpful in reducing anxiety and fatigue experienced during treatment with chemotherapy.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Other limitations/explanation: Completion of data collection forms by investigators increases potential bias. Only very short-term effects were measured.

Massage is a low-risk intervention that may be helpful to some patients during active chemotherapy treatment to reduce anxiety or fatigue. This study, however, does not provide strong supportive evidence due to multiple study design limitations.

To examine effects of music and visual imagery on anxiety and chemotherapy-induced nausea and vomiting (CINV) in patients receiving chemotherapy

Patients were assigned to the control group during their second cycle of chemotherapy and to the experimental condition during the third cycle of chemotherapy. Anxiety and CINV were measured before and after chemotherapy administration. Nature paintings were used for visual imagery, and instrumental Turkish music was selected for each image. Patients selected the image that was most appealing to them and were told to imagine being in the location of the painting. Patients were given the related music CD to listen to during chemotherapy with headphones.

• The study reported on a sample of 40 patients.
• Mean patient age was 59.65 ± 9.67 years.
• The sample was 77.5% male and 22.5% female.
• Of the sample, 80% had lung cancer, and all were receiving highly emetogenic chemotherapy.

The study was conducted at a single site, outpatient setting in Turkey.

Patients were undergoing active antitumor treatment.

A pre- and post-test repeated measures, single-group design was used.

• The Spielberger State-Trait Anxiety Inventory was used.
• Nausea was rated on a 100-mm visual analog scale (VAS).
• The Morrow Assessment of Nausea and Vomiting was used.

Anxiety declined from prechemotherapy to postchemotherapy administration in both conditions. Both pre- and postchemotherapy state anxiety levels were lower during the intervention course of treatment. CINV declined over time for both pre- and postchemotherapy administration. Both pre- and postchemotherapy CINV levels were significantly lower during the intervention condition.

This study does not provide any clear conclusions about the effects of music and visual imagery.

• The study had a small sample, with less than 100 participants.
• The study had risk of bias due to lack of a control group, blinding, random assignment, and an appropriate attentional control condition.
• The authors stated use of a 100-mm VAS but then stated that they grouped scores into 1 cm intervals. It is not clear if actual score differences were maintained, as this was not well described.
• The authors concluded that the intervention was effective based on analysis of differences before and after chemotherapy between the two study conditions; however, they did not show analysis of the change between pre- and postscores in each condition. This does not make sense as an approach to evaluate the effects.
• The study design had multiple risks of bias and threats to internal validity. Patients were assigned to the experimental condition in the third cycle—it is possible that anxiety and CINV simply declined over time, unrelated to the intervention.

Findings are inconclusive regarding the efficacy of music and visual imagery for anxiety and CINV during chemotherapy administration because of numerous study design and analysis limitations.

To evaluate the effects of kinesiophobia, quality of life, and home exercise programs on women with upper-extremity lymphedema

All patients underwent complete decongestive physiotherapy consisting of a combination of manual lymph drainage using the Foldi method, multi-layer bandages, remedial exercise, and skin care.

• The sample was comprised of 62 patients.
• Mean age of the sample was 56.7 years. 
• The sample was 100% female.
• All patients had upper-extremity edema following axillary node dissection after sentinel node biopsy as part of breast cancer therapy.
• Patients were included in the study if they had mild, moderate, or severe edema.
• Patients were excluded if attendance was irregular.

The study was conducted at a single-site outpatient setting at Dokuz Eylul University Hospital.

The study used a prospective trial design.

• Circumference was measured using a fiberglass tape measure.
• Water displacement in water cylinder was used to measure volume.
• Fear of movement was measured using the Tampa Scale Kinesiophobia (TSK) based on a Likert scale.
• Quality-of-life measurements were based on the Functional Assessment of Cancer Therapy for Patients With Breast Cancer (FACT-B) and four questionnaires.

• Edema of arm-volume significantly reduced after treatment with decongestive therapy (p = 0.000).
• Patient fear of activity decreased after treatment (p < 0.05).
• More exercise habits equaled less fear of activity (p < 0.05).

A correlation between severity of edema and fear of activity was established. Increased fear of activity showed to decrease quality of life.

• The study sample was small with fewer than 100 patients.
• Patients with poor attendance were eliminated from the study analysis.

Encouraging activity and education are important for the management of lymphedema in patients after sentinel node biopsy.

To examine the effect of oral beta-glucan on leukocytes, neutrophils, platelets, oral mucositis, and diarrhea in a group of patients with colorectal cancer who received adjuvant FOLFOX-4 and were at high risk for these side effects

Sixty-two consecutive patients admitted with colorectal cancer and treated with FOLFOX-4 between July 2009 and July 2010 were divided into two equal groups to receive beta-glucan 50 mg per day for at least one week with FOLFOX-4 for the first cycle or only FOLFOX-4. Leukocyte, neutrophil, and platelet counts were obtained, and oral mucositis and diarrhea were graded one day before and one week after chemotherapy.

• N = 62  
• MEDIAN AGE = 61 years (treatment); 55 years (control – no statistical difference) (range = 30–78 years)
• MALES: 61%, FEMALES: 39%
• KEY DISEASE CHARACTERISTICS: Colorectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients treated with FOLFOX-4

• SITE: Single-site    
• SETTING TYPE: Inpatient  
• LOCATION: Turkey

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

A retrospective study of consecutively-admitted patients.

• The National Cancer Institute's Common Toxicity Criteria (NCI, CTC) were used for grading oral mucositis and diarrhea.
• Cell counts were measured using a Siemens Advia^® 2120i hemogram device.

Oral mucositis and diarrhea were observed in six (19%) patients in the treatment group and in 13 (42%) patients in the control group. Statistical analysis could not be done because of the limited number of patients. There were no beta-glucan-induced side effects reported. There was no difference in the leukocyte and neutrophil counts before and after chemotherapy in the treatment group. The platelet count difference before and after chemotherapy was significant (p = 0.048). The difference between baseline and after chemotherapy was significant (p = < 0.01) for median leukocyte, neutrophil, and platelet counts in the control group.

Oral beta-glucan showed some effectiveness in reducing oral mucositis or diarrhea in patients receiving FOLFOX-4. Results are difficult to interpret because no statistical analysis could be performed comparing the two groups.

• Small sample (< 100)
• Risk of bias (no control group)
• Measurement/methods not well described
• Other limitations/explanation: The sample description was very brief. The discussion of quality of life when it was not measured was problematic. The study did not differentiate between patients who experienced diarrhea from those who had mucositis.

In this study, beta-glucan showed some relief of oral mucositis and diarrhea in participants. The study, however, was small, and statistical analysis was not possible due the number of participants enrolled. Additionally, all patients enrolled in this study were diagnosed with colorectal cancer and received FOLFOX-4 treatment, so the results may not be generalizable to other populations. At this time, other interventions should be considered to relieve symptoms associated with oral mucositis and diarrhea corresponding to chemotherapy treatment.

To compare the impact of intrathecal morphine (ITM) plus patient-controlled analgesia (PCA) versus PCA alone on morphine consumption, pain relief, and patient satisfaction after gynecologic-oncologic surgery (GOS)

Patients were randomized to an ITM plus PCA group or a PCA-only control group. Study patients received 0.3 mg ITM at the L3-L4 or L4-L4 vertebral level, and control patients received a needle puncture only. The same anesthesiologist performed all procedures. All patients received an initial morphine bolus of 0.05 mg/kg if pain was > 60 (0–100) on a Visual Analog Scale in the postanesthesia care unit. The PCA was reprogrammed for all patients to deliver a 1.5 mg bolus with a seven-minute lockout after patients were discharged from the postanesthesia care unit. Measurements were taken at 30 minutes and at one, three, six, 12, 24, and 48 hours.

• N = 56
• MEAN AGE = 73.13 years (SD = 7.25 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Gynecologic malignancies (uterine, ovarian, cervix, and other)

• SITE: Selcuk University, Department of Obstetrics and Gynaecology
• SETTING TYPE: Hospital
• LOCATION: Konya, Turkey

• PHASE OF CARE: Adult patients receiving active treatment 
• APPLICATIONS: Elder care and palliative care

Prospective, randomized, double-blinded study

Primary Measures

Pain scores were assessed using a 100 mm Visual Analog Scale (VAS, 0 mm = no pain, and 100 mm = worst pain imaginable). Patient satisfaction was measured using a 100 mm VAS (0 = very unsatisfied, and 100 = very satisfied), and cumulative PCA morphine consumption (mg) was calculated.

Secondary Measures

Patients were directly asked if they experienced nausea, vomiting, or pruritus. Rescue medication was administered for nausea and vomiting. The number of patients who verbally reported secondary measures and who received rescue medications were recorded.

Sedation was assessed using a five-point scoring scale (0 = fully awake, 1 = drowsy, closed eyes, 2 = asleep but easily aroused with light tactile stimulation or simple verbal command, 3 = asleep and aroused only by strong physical stimulation, and 4 = could not be aroused. Fatigue also was assessed on a four-point scale (0 = none, and 4 = severe). Respiratory depression was defined by a rate of less than 10 breaths per minute and was reversed by administering 0.1 mg of IV naloxone every five minutes until adequate respiration was restored.

Primary Outcomes

Patients in the ITM plus PCA group had a lower consumption of morphine (p < 0.0001 at all time points). There was no statistic difference in pain or patient satisfaction scores.

Secondary Outcomes

There was no statistic difference in sedation, nausea, pruritus, or fatigue between the two groups.

ITM plus PCA significantly reduced morphine consumption compared to PCA alone in the first 48 hours after GOS. The intervention, however, did not decrease pain scores or improve patient satisfaction. Both the intervention and the control group reported similar levels of the secondary side effects measured in this study.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Findings not generalizable
• Intervention expensive, impractical, or training needs

ITM plus PCA may be a viable option to decrease overall morphine consumption for patients in whom this is a desired outcome as it did not increase adverse side effects. However, the addition of ITM did not improve postoperative pain scores or overall patient satisfaction in patients receiving GOS.

To assess the efficacy of a whole wheat flour mix along with local ingredients (IATTA) with counseling to enhance dietary intake, physical activity, and quality of life (QOL)

Patients in the intervention group received 14 packets of IATTA every two weeks during appointments along with 30 minutes of counseling by a qualified nutritionist at each visit. They were advised to eat the contents of one whole packet along with their daily diet. Physical activity, such as walking, was also encouraged during counseling sessions. Patients in the control group received 30 minutes of counseling only by a qualified nutritionist at each visit.

• N = 63 (30 in intervention group and 33 in control group)
• MEDIAN AGE = 44 years (intervention group), 47.8 years (control group)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation, chemotherapy
• KEY DISEASE CHARACTERISTICS: Loss of more than 5% from pretreatment, body mass index less than 20 kg/m², hemoglobin less than 12g/dl, energy intake less than 1,500 kcl/d 
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusions: Patients with gastrointestinal disorders who were on anabolic steroids, taking synthetic oral supplements, and/or had a life expectancy of less than three months

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

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

• Prospective, randomized, controlled trial

Anthropometric measurements of nutritional status, physical activity, and QOL measurements:

• Body weight
• Mid-upper arm circumference (MUAC)
• Dietary questionnaire: Patient Generated Subjective Global Assessment
• Physical activity questionnaire: Indian Migrant Study Physical Activity Questionnaire
• QOL assessment: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ-C30) questionnaire

Fifty-one percent of patients completed the study. Patients in the intervention group tended to gain weight, but it was not statistically significant. Patients in the control group showed statistically significant weight loss (p = 0.003) and reduced MUAC (p = 0.006). Body fat increased significantly in the intervention group (p = 0.002) and decreased significantly in the control group (p = 0.032) at the end of the six-month intervention period from baseline. At the end of six months, significant energy intake increased in the intervention group (p = 0.001) with carbohydrates (p = 0.001), protein (p = 0.001), and fat (p = 0.006), respectively. Physical activity recall showed significantly reduced activity in the control group (p = 0.004). Patients in the intervention group did not show a change in physical activity. The intervention group showed a statistically significant improvement in QOL in factors such as fatigue (p = 0.002) and appetite loss (p = 0.006). The control group showed a statistically significant decrease in the domains of global health status (p = 0.018) and social functioning (p = 0.004). At the end of six months, global health status, social functioning, appetite, and fatigue showed significant differences between the two groups (p < 0.001).

Nutrition therapy and supplementation within palliative care may improve QOL and stabilize weight in patients with cancer and cachexia. Nearly 50% of patients did not complete the study, so further study is indicated.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%  
• Female patients only
• Homogeneous population—not diverse

Nutrition counseling is imperative through all phases of cancer care. Further study of nutrition counseling and intervention should include QOL measures, such as physical activity, social functioning, and pain status.