To describe the effects of a postsurgical home exercise intervention implemented immediately after hospital discharge on cancer-related fatigue (CRF), other symptoms, functional status, and quality of life (QOL) in individuals with non-small cell lung cancer (NSCLC)

Patient education in a hospital regarding exercise was followed by a home visit from a nurse educated on warm-up exercises, light intensity exercise such as walking, and balance exercises with a Wii. Patients were instructed to increase walking to goal of 30 minutes a day in week 6.

• N = 7  
• MEAN AGE = 64.6 years (range = 53–73 years)
• MALES: 29%, FEMALES: 71%
• KEY DISEASE CHARACTERISTICS: All received lobectomy for NSCLC; average of 5.9 comorbidities
• OTHER KEY SAMPLE CHARACTERISTICS: Five of seven patients started chemotherapy in week 5.

• SITE: Single site    
• SETTING TYPE: Home    
• LOCATION: University teaching hospital in Michigan

• PHASE OF CARE: Active antitumor treatment

Pilot study

• Brief Fatigue Inventory (BFI)
• MD Anderson Symptom Inventory (MDASI) core and lung module (symptom severity)
• Medical Outcomes Short Form-36 (MO SF-36 v.2) acute recall (function)
• Ferrans and Powers Quality of Life Index (FP QLI) (QOL)

• Fatigue: Presurgery = 3.5, postsurgery = 4.8, and week 6 = 2.8
• Overall physical function: Presurgery = 49.8, postsurgery = 31.5, and week 6 = 45.9
• QOL: Presurgery = 23.5, postsurgery = 22.4, and week 6 = 23.8

Cancer-related fatigue decreased below presurgery levels after six weeks of exercise intervention.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition) 

Home-based exercise may reduce cancer-related fatigue in patients with NSCLC postsurgery.

• To assess the effectiveness of a mindfulness-based stress reduction (MBSR) intervention for mood, breast- and endocrine-specific quality of life, and well-being after hospital treatment in women with stage 0 to III breast cancer.
• To compare MBSR to usual care and its effect on mood and disease-related quality of life.
• To measure if a dose-related effect was evident with formal, eight-week MBSR practice.

The intervention consisted of an eight-week MBSR program closely following the Kabat-Zinn method. The intervention involved 2- to 2.25-hour classes and a 6-hour retreat. Home practice was recommended for 45 minutes, six to seven days per week. Outcomes were measured at baseline, weeks 8 to 12, and weeks 12 to 14. A wait-list control group received usual care.

• A total of 229 patients (100% female) participated.
• Mean age was 49 years (SD = 9.26 years) in the treatment group and 50.1 years (SD = 9.14 years) in the control group.
• Patients had been diagnosed with stage 0 to III breast cancer; 47% had stage II cancer.
• Participants were recruited from The Haven, a charitable day center that provides free psychosocial services for patients with breast cancer. All patients had received an average of 30 hours of support prior to entering the study.

• Single site
• Outpatient
• The Haven, London, England

• Patients were undergoing long-term follow-up.
• The study has clinical applicability for late effects and survivorship.

The study used a randomized, controlled trial design.

• Profile of Mood States (POMS) questionnaire
• Functional Assessment of Cancer Therapy (FACT)–Breast and Endocrine Symptoms 
• World Health Organization (WHO) (Five) Well-being Index

• The study revealed significant differences between the groups in regard to POMS subscale scores (p < 0.001): depression (p = 0.017), anxiety (p < 0.001), anger (p = 0.005), vigor (p < 0.001), fatigue (p = 0.002), and confusion (p = 0.002).
• Participants completed a mean of 19.58 hours (standard deviation = 11.49 hours) of home MBSR practice over eight weeks, or 21 minutes per day. Increased hours of MBSR practice improved POMS scores at T3 for overall mood (p = 0.004), vigor (p = 0.02), fatigue (p = 0.03), and anxiety (p = 0.01). POMS scores improved at T2 and T3 for anger (p = 0.005 and 0.02, respectively), confusion (p = 0.04 and 0.001, respectively), and well-being.

MBSR significantly improved mood and reduced confusion.

• The study lacked an appropriate control group.
• The control group was not attention controlled, which limited the interpretation of between-group differences.
• The setting was unique, and the intervention used many resources, which made implementing and generalizing findings difficult.
• The study had a risk of bias due to lack of blinding.

Although further study is needed to measure MBSR and its impact on depression and anxiety, in this sample, home-based practice was feasible and improved mood. In practice and education, nurses can promote components of MBSR, such as breathing, yoga, relaxation, meditation, seeking support resources, and gentle stretching.

To evaluate the efficacy and safety of long-acting release (LAR) octreotide for the prevention of chemotherapy-induced diarrhea (CID)

This prospective, randomized clinical trial compared the administration of octreotide LAR 30 mg IM every four weeks beginning with first-cycle to the administration of a physician’s choice of medication in a group of patients with colorectal cancer starting adjuvant or first-line treatment. Patients received combination chemotherapy with fluorouracil, capecitabine, and/or irinotecan. Treatment with octreotide LAR was continued for six months or until chemotherapy discontinued or until the patient developed unacceptable toxicity related to the study drug (whichever occurred first). The choice for the treatment for diarrhea for both arms was at the physicians' discretion, but the control group could not receive octreotide LAR. Patients were stratified according to the use of irinotecan.

• N = 139  
• AGE RANGE = 22–78 years
• MALES: Treatment group 45.6%; control group 42.3%, FEMALES: Treatment group 54.4%; control group 57.7%
• KEY DISEASE CHARACTERISTICS: Patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan.
• OTHER KEY SAMPLE CHARACTERISTICS: Sites of metastatic disease, colostomy, and type of surgery

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Brazil at multiple institutions

• PHASE OF CARE: Active antitumor treatment

Randomized, multi-centered, open-labeled, phase III trial

• To evaluate the incidence and severity of diarrhea, a patient diary was given to patients at each visit, and the completed tool was collected at the next visit. The diary was used to record patient events. 
• All adverse events (related to laboratory or dose reductions) were collected through medical records.
• A Functional Assessment of Chronic Illness Therapy For Patients With Diarrhea (FACIT-D) scale was collected at each visit. 

139 patients were randomly assigned. Most received a fluorouracil (treatment  98.5%, control  98.6%) or oxaliplatin (treatment 76.5%, control 63.4%) containing regimen. The rate of diarrhea was 76.1% in the treatment group (n = 68) and 78.9% in the control group (n = 71). Treatment with octreotide LAR did not prevent or reduce the severity of chemotherapy-induced diarrhea.

There was no benefit in using octreotide LAR prophylactic in patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan.

• Risk of bias (no blinding)
• There was a small number of patients who received chemotherapy with other regimens containing irinotecan. There was also the smaller proportion of patients presenting with grade 3 or 4 diarrhea. 

There was no benefit in using octreotide LAR prophylactic in patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan. This has also been evaluated in other studies that have looked at octreotide LAR using escalation doses of 30 or 40 mg, and the results were similar. Per the authors of this study, the short-acting octreotide remains the formulation of choice in the treatment of CID.

The intervention was a formal education/orientation program with oral and written information for patients and their significant others upon beginning radiation therapy. The control group of patients receiving radiation therapy and their significant others received information during their consultation visit via the physician, several pamphlets, and individual teaching by the nurse.

• The study reported on a sample of 100 people (the patient and his or her significant other counted as two people).
• A total of 85 people completed the postintervention assessment: 49 in the intervention group and 36 in the control group.
• All diagnoses and all stages of cancer were included.
• All participants were new to radiation therapy.

A randomized controlled trial design was used.

• State-Trait Anxiety Inventory (STAI)Form Y–State anxiety subscale
• 20-item self-report index
• Profile of Mood States (POMS)–Total Mood Disturbance measure
• 10-item multiple choice test developed for study to measure radiation knowledge

The information orientation session had no significant effect on anxiety, general distress, adherence to treatment, or knowledge about radiation. The program did increase satisfaction with care, use of psychological counseling, and outside support resources.

• The study had a small sample size.
• The study did not report baseline measurements or screening of anxiety prior to intervention.

To investigate the use of extra-orally applied near infrared phototherapy for the reduction of oral pain secondary to chemotherapy and radiation therapy induced mucositis in adult and pediatric HSCT patients.  

Eighty HSCT patients were divided into regular and low risk groups, and then into experimental and placebo groups. The experimental groups received gallium-aluminum-arsinide light emitting diode (LED) once daily, while the placebo group also received a similar appearing placebo treatment daily, beginning on day of HSCT (day 0) through day 14. The LED was applied extra-orally, by placing the light source in contact with the cheeks and anterior throat. The blinded evaluators examined the patients three times/week scoring their oral tissues, and patient reported pain assessments.

The sample was comprised of 80 patients age 3-74 years.

Males (%): 55 and Females (%): 45

Key Disease Characteristics: Aplastic anemia, neuroblastoma, AML, NHL, CLL, SLL, ALL, Hodkin’s disease, PNT, MES, Ewing's sarcoma, sickle cell anemia, CML, TC, HLH, WAS, MDS, osteoporosis, lymphoma, multiple myeloma, POEMS, amyloidosis

Other Key Sample Characteristics: All patients received conditioning therapy with melphalan.

Site: Multi-site

Setting Type: Not specified

Location: Children’s Hospital of Wisconsin, University of Alabama - Birmingham, The Children’s Hospital of Alabama

Phase of Care: Active treatment

Randomized, double-blinded, placebo-controlled

• WHO pain assessment scale
• NCICT GI Criteria for Adverse Events
• OMAS erythema or ulceration scale
• Patient diary form with questions concerning mouth pain -  ADULT - VAS (no pain and most severe pain possible) PEDIATRICS - Wong Baker FACES pain scale
• Patient diary using the same scales adapted to measure the impact on swallowing from no trouble to unable to swallow anything (including saliva)
• Patient report regarding eating normally; eat only soft solid foods; consume only liquids; or could not tolerate any food or liquids.
   

There were no significant differences in the WHO clinical examination scale between any of the groups. The other scales used also did not elicit significant differences.

Although it was not statistically significant, the data suggested a trend for the experimental groups to have general improvements in all of the scales.

Small sample <100

Groups were not split into children versus adults.

Inconclusive, would need much more research to demonstrate effectiveness. The positive note was that this treatment is applied extra-orally, making it more tolerable during periods of oral mucositis. This treatment would require education for the healthcare team as well as added cost for the use of the technology.

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Palliative care

Per the authors, evidence exists to support olanzapine in highly emetogenic regimens. The Navari (2011) trial was the strongest study to support the use of olanzapine. Toxicity in all included trials demonstrated little side effects. Only one trial described sleepiness during chemotherapy. Olanzapine is a safe and more costly option to use instead of NK-1 antagonists. When used with other antiemetics such as metoclopramide there is a role in prevention, and as a single agent it shows efficacy in delayed CINV as well.

There were only three studies in each group. Only the Shumway trial was double-blinded, but it was a small trial. All the breakthrough trials were by the same investigator and included less than 110 patients.

Olanzapine may have a role in preventing CINV and delayed CINV but there is still limited research. The most recent trial for delayed CINV is a small trial but is double-blinded. Further research is indicated.

To evaluate efficacy and effective doses of a dimethyl sulfoxide (DMSO) sodium bicarbonate combination for refractory pain in patients with cancer

Participants received 8 infusion cycles of 20–60 ml of DMSO mixed with 1.4% of NaHCO3 daily for 10 days with 2 days off between cycles. Data were recorded at baseline, and at 3, 10, 20, 30, 60, and 96 days. Patients were allowed to take any medication, supplements, or herbal preparations as usual for them. The DMSO concentration was increased incrementally until pain was completely under control.

• The study reported on 26 patients.
• The mean age was 56.8 years, with a range of 17–72 years.
• The sample was 38% female and 62% male.
• All patients had life expectancies of six months or less.
• A variety of cancer types were included, with primary liver, lung, and colorectal cancers the most prevalent.

The study was conducted at a single-site, inpatient setting in Hanoi, Vietnam.

This was an open label, prospective trial.

Patients used a verbal pain scale ranging from 0 (no pain) to 4 (extreme pain).

After 2 cycles, 11 (43%) patients achieved 20% or more reduction in pain and were discharged from the hospital to outpatient therapy. After 3 cycles, an additional 23% achieved this level of pain control. All but 4 patients achieved pain control at this level by day 96. By day 96, 83% of patients used less pain medication. No major negative effects occurred related to the infusion solution. The most frequent side effects were headache and chills during and after treatment. These effects resolved within 2 hours. The proportion of patients with other symptoms also was reported to decline over the course of the study.

This preliminary information suggests that this DMSO and NaHCO3 infusion can have a positive benefit for patients in the relief of refractory pain and is not associated with severe adverse effects.

• The sample size was small, with fewer than 30 patients.
• This was an open-label design with no control or comparison group.
• The single measurement method for pain did not have established reliability and is a rather gross measure to use in defining complete pain control.
• The authors reported a decline in the prevalence of other symptoms, but they did not provide information on how these were measured or how symptom absence was determined.

Findings suggest that this DMSO infusion may be a safe alternative for pain control in terminal patients with severe pain that is not otherwise well controlled. However, the study does not provide sufficient support for this intervention. The positive findings here suggest that further well-designed research on DMSO infusion is warranted.

To investigate the effectiveness of dance movement therapy on treatment-related symptoms

The program consisted of six 1.5-hour sessions of dance movement therapy twice weekly for three weeks during radiotherapy. Therapy involved use of stretching, movement to exercise upper extremities, improvisational dance, and expressive movement. Participants were encouraged to share experience and communicate and to relate movement to personal experiences of breast cancer and treatment. Patients were randomized to the intervention or a wait-list control group.

• N = 139 (ITT analysis), 127 with complete data   
• MEAN AGE = 49 years
• FEMALES: 100%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer, and about 80% were also receiving chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Over half were married, and 65% had education at secondary level or below.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Hong Kong

• PHASE OF CARE: Active antitumor treatment

• Single-blind randomized controlled trial

• Perceived Stress Scale (PSS)
• Brief Pain Inventory (BPI)
• Brief Fatigue Inventory (BFI)
• Hospital Anxiety and Depression Scale (HADS)

All patients showed decline in fatigue scores over time with no difference between groups. Sleep disturbance declined in the study group and increased slightly in the control group, but differences were not significant. Anxiety and depression remained stable in both groups. Pain severity and pain interference declined in the dance group and increase in the control group (p < 0.05). The size of effect for pain was moderate (d = 0.35). Perceived stress declined in the dance group compared to controls (p < 0.05). The program had a high completion rate.

Participation in this group dance movement therapy was associated with decline in pain severity and interference.

• Risk of bias (no appropriate attentional control condition)
• There is no description of the type of pain, use of any pain medications, or other interventions in either group. The group interaction may have had as much to do with any reduction in symptoms as the actual dance activities.

The dance movement therapy program used here combined rhythmic and expressive movement with group sharing and support. The contribution of each of these components cannot be differentiated, but results showed positive benefits in terms of pain and perceived stress. There were a number of study limitations; however, the program completion rate was high, and there were no adverse effects, suggesting that this type of intervention can be practical to provide during active radiotherapy treatment.

To evaluate the efficacy of IV ramosetron plus dexamethasone compared to granisetron plus dexamethasone for the prevention of acute chemotherapy-induced nausea and vomiting (CINV)

Subjects were randomized to receive 0.3 mg ramosetron plus 20 mg dexamethasone or 3 mg granisetron plus 20 mg dexamethasone on day 1 prior to chemotherapy. Patients were evaluated over a 24-hour period. All vomiting episodes were recorded by the patient. Every 6 hours, the degree of nausea was evaluated.

• The sample consisted of 285 participants.
• The mean age of participants was 51 years with a range of 22–74.
• The sample was 60.8% female and 38.2% male.
• Diagnoses were breast (43.2%) and lung (29.1%), as well as nasopharynx, mouth, rectum, liver, bladder, stomach, esophagus, testis, brain, and other.
• All patients were receiving emetogenic chemotherapy including cisplatin, doxorubicin, epirubicin, or oxaliplatin.
• Patients were not eligible if they had symptoms of vomiting for at least one week before study entry.

The study was conducted at multiple sites in Taiwan.

All patients were in active treatment.

This was a randomized trial (double-blind), parallel group trial.

Complete response (CR) was defined as no vomiting and no rescue medication. The date, time, and number of episodes of vomiting or retching were recorded. Patients rated their levels of nausea using a 10-cm visual analog scale (VAS) tool. Total control was defined as no vomiting and nausea rating of less than 0.5 cm on the VAS tool. A proportion of subjects received rescue drugs.

• No difference was found between the ramosetron plus dexamethasone group and the granisetron plus dexamethasone in CR rates.
• No statistically significant differences were found in the proportions of patients with vomiting, nausea on the VAS scale, or rescue medication.
• No differences were found in drug-related adverse events between the two treatment arms.
• The most frequent adverse event reported was hiccups in both groups.
• Overall, 77.4% of patients receiving ramosetron and 82% of patients receiving granisetron achieved CR.

Ramosetron plus dexamethasone regimen was found to be equivalent to granisetron plus dexamethasone in CR rate during the acute phase.

• Patients receiving both highly and moderately emetogenic chemotherapy were combined, with no subgroup analysis for different levels of emetogenicity.
• Patient compliance with diary recording was not discussed

Ramosetron plus dexamethasone regimen was found to be as effective as granisetron plus dexamethasone in the management of CINV during the acute phase, suggesting that ramosetron could be used as an alternative to other 5-HT₃ receptor antagonists in highly and moderately emetogenic chemotherapy.

To examine the effects of administration of synthetic ghrelin on appetite and oral intake in patients with advanced esophageal cancer during chemotherapy

Patients were randomized to receive either ghrelin at 3 µg/kg over 30 minutes twice daily or placebo for seven consecutive days (days 1–7 of therapy) intravenously. All patients also received the same protocol of IV fluid of 3 L/day from days 1–3 and 2 L/day from days 4–7. Appetite was scored prior to each meal. A registered dietitian determined caloric intake by measuring the weight of each dish before and after every meal.

• The study reported on a final sample of 40 patients.
• Mean patient age was 63.4 years.
• The sample was 87.5% male and 12.5% female.
• All patients had stage II or higher esophageal disease. All were receiving cisplatin-based chemotherapy.

• Single site 
• Inpatient setting
• Japan

Patients were undergoing active antitumor treatment.

The study was a placebo-controlled randomized controlled trial.

• Appetite visual analog scale (VAS)
• Caloric intake
• Rapid turnover protein levels: prealbumin, transferrin
• Common Terminology Criteria for Adverse Events

Dietary intake declined after cisplatin administration to the lowest levels on days 5–7. It took another 4–7 days for oral intake to recover and enable discharge from the hospital. The decline in dietary intake was less in the ghrelin group (p = 0.0027). On day 7, intake with ghrelin was 26.7 kcal/kg/day compared to 23.1 kcal/kg/day for those receiving placebo. Prealbumin was higher in those on ghrelin (p = 0.042), and transferrin was higher with ghrelin (p = 0.037) compared to those levels in the placebo group. The severity grades of anorexia and nausea were lower with ghrelin (< 0.02).

Findings suggest that administration of ghrelin during cisplatin-based chemotherapy was effective in reducing anorexia and maintaining caloric intake compared to placebo.

• The study had a small sample size, with less than 100 participants.
• Lack of blinding had an associated risk of bias.
• Unintended interventions or applicable interventions were not described that would influence results.
• The intervention was expensive, impractical, or required training.
• The use of antiemetics during treatment was not described, so it is unclear whether there were differences between groups that could have affected outcomes.
• Although findings were statistically significant, the actual difference in caloric intake appears to be fairly small.
• The sample included only patients who had no previous chemotherapy, and physicians had discretion to exclude patients based on no particular criteria. It is unclear whether this could have produced sample bias. 
• This protocol would only be feasible in an inpatient setting.

Findings suggest that ghrelin as administered in this study may be beneficial to preserve appetite and nutritional intake during chemotherapy.  As done here, ghrelin and fluid administration would only be practical in an inpatient setting.