To evaluate whether Bojungikki-tang has beneficial effects on fatigue and overall quality of life in patients with cancer.

Patients were randomized to the experimental group or the wait-list control group. The experimental group received Bojungikki-tang for two weeks. Bojungikki-tang was administered as granules containing a mixture of 10 medicinal plants given three times daily. Patients were randomized through computer generation. Patients were recruited through newspaper and hospital advertisements.

• The final sample included 36 patients (37.5% male).
• Mean age was 52.6 years. 
• Diagnoses included breast cancer (27.5%), stomach cancer (12.5%), lung cancer (12.5%), colon cancer (12.5%), and other (35%).

Unknown

The study was a randomized, controlled trial.

• Evaluation forms included the Visual Analogue Scale of Global Fatigue, which was used as the primary outcome variable.
• The secondary outcome was measured using the Functional Assessment of Cancer Therapy–General (FACT-G), the FACT-Fatigue (FACT-F), and the Trial Outcome Index–Fatigue (TOI-F).

The experimental group had statistically significant improvements in VAS-F scores, as well as FACT-G, FACT-F, and TOI-F (p < 0.05) at week 2.

The study had a possible effect from the study drug, although p-values were on the edge of significance. The benefit shown suggests additional study is required in a larger, placebo-controlled trial.

• The study had no placebo in place, and the treatment time was short.
• The plant mixture was not controlled for variability.
• One patient experienced an increase in BUN and creatinine above the reference ranges, and other adverse effects were reported (flatulence and dyspepsia); therefore, the potential for harm needs to be considered and the risks weighed versus potential benefits if additional study is to be performed with a larger population.
• Exclusion criteria for patients needs to be more rigorous and include consideration of antihypertensive medication and other drug interactions and baseline renal function.

Patients pursuing this treatment should be educated on the current need for additional research.

To evaluate the efficacy and complications of continuous epidural analgesia to improve its efficacy for control of cancer-related pain

Most patients received morphine, bupivacaine, and ketamine via continuous epidural infusion. Dosing was determined by converting the daily total opioid dose to an IV morphine equivalent. The epidural morphine was delivered at 25%–17% of the IV morphine dose. Bupivacaine 12.5–25 mg per day and ketamine 10–20 mg per day were administered at 2 mL/h and varied according to pain location, severity, and type, as well as progression of disease. Additional adjuvant therapies were used and included antiepileptic drugs, antidepressants, anti-inflammatory drugs, and steroids. Pain levels were evaluated at baseline and at two weeks postepidural.

• The study reported on 96 patients.
• Nine patients were 40 years old or younger, 35 patients were 41–59 years old, and 52 patients were 60 years or older.
• Patients had been diagnosed with terminal lung, upper genitourinary, hepatobiliary, pancreatic, rectosigmoidal, urogenital, or other (10.4%) cancers.
• The majority of patients (91.6%) had pain in the chest, abdomen, back, sacral, or lower extremity, and 8.3% had pain in the head, neck, and upper extremity.

The study was conducted at a single site in Korea. The setting type was not specified.

• Patients were at the end-of-life phase of care.
• This study has clinical applicability for elder care and palliative care.

The study design was a retrospective chart analysis.

• Paired sample t-tests were used to evaluate the morphine-equivalent drug dose (MEDD).
• Statistical analysis was performed using SPSS software version 13.0.

The MEDD decreased from 213.4 mg (SD = 221.7 mg) per day to 94.1 mg (SD = 145.0 mg) per day at two weeks follow up. Prior to receiving the epidural, 78.1% of patients reported severe pain; at the two-week follow up, only 19.6% reported severe pain (p < 0.05). Mild catheter complications occurred in 15.6% of patients. Moderate complications occurred in 14.6% of patients, including infection that had to be controlled with antibiotics or removal of the catheter.

Continuous epidural anesthesia is an effective pain control method for patients with cancer at the end of life. However, risk of infection and complications exist because of catheter placement.

• The sample size was small, with fewer than 100 patients.
• A risk of bias exists because of the lack of a control group, blinding, and appropriate attentional control condition.
• The subject withdrawal rate was 10% or greater. The study had an extremely high attrition rate because of patient death (over a two-week span, the sample was reduced from 96 to 56 patients).
• Variations in documentation practices within the medical record were a weakness of this study.
• This was a retrospective study.

For patients seeking more pain control, continuous epidural infusions may be an option for pain relief. The charts reviewed cited inappropriate pain control (78.1%) and intolerable side effects (21.9%) as the reasons for placing the epidural, which are key factors in working to improve comfort in patients with terminal cancer.  Risks of complications include infection, occlusion, catheter removal, risk of respiratory depression, motor block, hypotension, sensory deficits, and gastrointestinal and genitourinary function that must be evaluated while the catheter is in place. In patients with terminal cancer, patient and caregiver education is important.

To test the hypothesis that treatment with an oil-in-water emulsion (WO1932) leads to more rapid skin hydration, improves skin barrier function, and reduces pruritus in patients after radiation therapy

Patients were randomized to a treatment group or control group. In the treatment group, the oil-in-water emulsion was applied twice a day over six to eight weeks, starting after radiation therapy was completed. Sauna, swimming, and use of any other skin care product were not allowed. Clinical assessment was done after week one and at the end of the study.

• N = 64
• AGE: Not provided
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: All were experiencing radiodermatitis with an ONS score of 0–3
   

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

• PHASE OF CARE: Transition phase after active treatment

•  Open-label RCT

• ONS skin reaction scoring (not described)
• Transepidermal water loss
• Visual analog scale (VAS) for pruritus
   

Pruritus decreased in all patients but more in the treatment group in weeks one, two, three, and five (p < .04). There was no significant difference between groups in skin scores overall. There was no difference between groups in transepidermal water loss.

This study does not provide strong evidence in favor of the oil-in-water emulsion tested here. Findings suggest the emulsion was helpful in reducing pruritus compared to no treatment at all.

• Small sample (< 100)
• Risk of bias (no blinding) 
• Risk of bias(sample characteristics)
• Measurement/methods not described
• Other limitations/explanation: In one place, authors report that measures were done after week one and eight yet provide data for multiple other weeks. No demographic information is provided. Inclusion criteria state that patients had 0–3 skin scores, which means, at 0, there was no radiodermatitis. No clear baseline data or comparison of skin scores are provided.

This study does not provide strong evidence for evaluation of effectiveness of the oil-in-water emulsion tested here.

To analyze the available literature and define clinical practice guidelines for the use of the following agents for the prevention and treatment of oral mucositis (OM): allopurinol, midline mucosa-sparing radiation blocks, payayor, pentoxifylline, timing of radiation therapy (morning versus afternoon), pilocarpine, bethanechol, chewing gum, propantheline, and tetrachlorodecaoxide

• DATABASES USED: MEDLINE
• KEYWORDS: Oral mucositis, cancer therapy, supportive, palliative, prevention, treatment, and saliva
• Inclusion and exclusion criteria were not listed in this report, but, rather, were referenced from the criteria listed in another referenced study.

A total of 99 references were retrieved. Of these, 18 were excluded based on the inclusion/exclusion criteria (which was not stated in the article). Of the remaining 81 papers, 49 pertained to agents of natural origin and the results on those agents were reported separately. This manuscript reported the results of the review of the remaining 32 papers that tested interventions that did not fit in any of the other categories and were classified as miscellaneous agents.

Studies were evaluated based on the list of major and minor flaws published by Hadorn. Level of evidence was assigned for each intervention based on the Somerfield criteria. A well-designed study was defined as a study with no major flaws per the Hadorn criteria. Findings from the reviewed studies were integrated into guidelines based on the overall level of evidence for each intervention.

• A final sample of 32 papers addressing 10 interventions were included in the report.
• The numbers of patients and sample ranges across all studies were not reported.
• Patient populations included patients receiving high-dose chemotherapy before stem cell transplantation, patients receiving radiation therapy (RT) for head and neck cancer, and patients receiving bone marrow transplantation.

PHASE OF CARE: Active treatment

Suggestions were made against the use of systemic pilocarpine administered orally for prevention of OM during RT in patients with head and neck cancer and in patients receiving high-dose chemotherapy with or without total body irradiation, prior to hematopoietic stem cell transplantation as well as against the use of systemic pentoxifylline administered orally for the prevention of OM in patients undergoing bone marrow transplantation. No guideline was possible for any other agent reviewed because of inadequate or conflicting evidence.

None of the agents reviewed was determined to be effective for the prevention or treatment of OM. This review was inadequate and difficult for the reader to understand. The methods section was missing needed information to assess the interventions and the associated recommendations.

• The scope of the analysis was too large, as 32 studies were included from which the review panel attempted to make recommendations about 10 different interventions.
• The level of evidence was not explained to the reader, making it difficult to assess the results obtained and impossible to know if the study selection was biased.
• The authors stated that the criteria for a well-designed study was no major flaws per the Hadorn criteria but did not tell the reader what the criteria were.
• The authors were not clear if only well-designed studies were used exclusively.

Many products on the market claim to prevent or treat OM. Nurses need to be well informed before recommending any products or interventions to patients. Further research is needed. 

To evaluate whether pre- and postoperative physical exercise affect quality of life and symptoms in patients undergoing radical cystectomy

Patients were randomized to a standard care or intervention group. Standard care included preoperative nutritional screening counseling and the use of oral supplements as needed, patient education, and standard mobilization postoperatively by walking during each shift with supervision once daily. The intervention included all aspects of standard care plus a preoperative exercise program and a more comprehensive postoperative exercise program with related patient education 14 days prior to surgery. Prior to surgery, a phone call after one week was done to promote adherence to the program. Postsurgery, the intervention group had physical therapy sessions two times per day including progressive muscle strength and endurance training. The difference between groups at four months after the intervention were reported.

• N = 100
• MEAN AGE = 70 years (range = 46–91 years)
• MALES: 66%, FEMALES: 34%
• KEY DISEASE CHARACTERISTICS: All had surgery for urinary diversion
• OTHER KEY SAMPLE CHARACTERISTICS: 57% married and living with a partner

• SITE: Single-site  
• SETTING TYPE: Multiple settings  
• LOCATION: Denmark

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)
• Charlson Comorbidity Index (CCI)
• Nutritional risk screening tool

Those in the intervention group reported reduced symptoms of constipation and flatulence. Compared to the intervention group, those in the standard care group reported reduced insomnia (p = 0.04) and a clinically relevant, but not statistically significant, reduction in fatigue. There were no other differences between groups in symptoms.

The perioperative multicomponent rehabilitation program studied here did not result in reduced fatigue or improvement in overall quality of life compared to those who received standard care.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Patient adherence to exercises preoperatively was not described.

A more intensive exercise and educational counseling program provided perioperatively did not result in better patient outcomes related to fatigue four months after surgery for this group of patients. The lack of information about patients’ adherence to both pre- and postoperative exercise recommendations is a limitation of this report. Additional research on the impact of perioperative rehabilitation therapies in various patient groups would be of benefit.

To investigate the feasibility of two different training programs including resistance and aerobic exercise in a small cohort of patients with advanced gastrointestinal cancer undergoing palliative chemotherapy; the study aimed to investigate potential effects of these programs on quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) as well as on physical performance, biological parameters, and activities of daily living

• N = 26 randomized (21 completed)  
• AVERAGE AGE = 55 years
• MALES: 10, FEMALES: 11
• KEY DISEASE CHARACTERISTICS: Gastrointestinal (GI) tumors with advanced disease; 48% new diagnosis; varied treatment modalities
• OTHER KEY SAMPLE CHARACTERISTICS: Some patients had a history of operation or radio-chemotherapy at initial diagnosis and were undergoing palliative chemotherapy.

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: Supervised exercise (does not specify)

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Two-group randomized trial

• Quality of Life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Physical Performance: Muscular strength and cardiorespiratory fitness
• Daily Physical Activity: Wearing a SenseWear^® wristband; Freiburg Questionnaire of Physical Activity
• Biologic Parameters: Peripheral venous blood parameters
• Exercise preference

The postinterventional fatigue level decreased in both subgroups, suggesting that both programs seem to have positive effects on fatigue in patients undergoing palliative chemotherapy.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)

Further prospective, controlled trials with larger sample sizes are needed to adequately analyze the efficacy of these programs in patients with advanced gastrointestinal cancer currently undergoing palliative chemotherapy.

Postoperative fatigue and deterioration in functional capacity have been correlated with postoperative weight loss. Nutritional support to enhance the regain of weight may be beneficial to convalescence.

Patients received soy protein supplements and dietician home visits and traveled five times during the 180 days in the postoperative period after discharge.

The study included 32 patients undergoing elective colorectal surgery; 22 (69%) had cancer.

The study was conducted in a community setting in Denmark.

Patients were undergoing the active treatment, postoperative phase of care.

This was a randomized trial with a usual care comparison group; patients and investigators were not blinded to treatment assignment.

• Ordinal fatigue scale (1–10) 
• General Well-Being (GWB)
• Quality of Life Index (QLI)
• Quality of life visual analog scale (VAS)
• Lambert Disability Screening Q (body care, mobility, sensory, social)
• Functional measures of hand grip
• Forced Expiratory Volume (FEV₁)

The intervention group consumed significantly more protein than the control group. The intervention group slowly gained weight (p = 0.005) and body mass (p = 0.002) compared to the control group. Both groups had comparable scores for fatigue, functional status, and disability at discharge, 160 days, and the conclusion of the evaluation period.

• The study had a small sample size.
• Outcome assessors were not blinded to treatment condition.

To examine the effects of an expressive writing intervention on cancer-related distress, symptoms of depression, and mood in women with early-stage breast cancer

Women were randomized to an expressive writing group or a control group. Both groups were instructed to write for 20 minutes once a week over a three-week period. On each writing day, patients were contacted by telephone to initiate the writing session and contacted again after 20 minutes to terminate writing. Patients in the expressive writing group were instructed to write about a distressing event and to explore their deepest emotions and feelings about the experience. Control group patients were asked to write about their daily activities in a detailed and objective manner. Study questionnaires were completed at baseline and at three and nine months postintervention.

• The study reported on a sample of 437 female patients.
• Mean patient age was 53.6 years.
• All patients had breast cancer (stage I or II) and were contacted regarding study participation within three weeks of initial breast surgery.
• The majority (80%) of patients were married or partnered, and 64.5% were retired or unemployed.

• Multisite
• Home setting
• Denmark

Single-blind, randomized controlled trial with an active control group

• Impact of Event Scale
• Beck Depression Inventory
• Profile of Mood States
• Social Constraints Scale
• Toronto Alexithymia Scale

The expressive writing group showed significant changes in negative and positive mood immediately after the writing sessions (d = 0.84–1.04, p < 0.001). When age and baseline measures were included in analysis as covariates, there were no significant effects or group-by-time interactions.

Investigators could not confirm the hypothesis that, compared to patients in an active control group, patients in an expressive writing group experience less cancer-related distress.

• Fifteen percent of the sample initially randomized dropped out or was lost to follow-up.
• Investigators did not report whether patients were actively receiving treatment during the study.
• Baseline outcome data were not reported.

This study does not provide evidence to support expressive writing as an intervention to reduce anxiety and symptoms of depression in women with breast cancer.

This systematic review included trials of opioids for the treatment of dyspnea secondary to any cause.

Eighteen randomized, double-blind, placebo-controlled crossover trials were evaluated. Meta-analyses were performed on all included studies and on various subgroups (e.g., nebulized opioids).

Patient populations were mixed, with 2 of the 18 trials including patients with a cancer diagnosis only and one of the 18 trials including patients with cancer with other advanced diseases.

A strong effect of non-nebulized opioids relative to placebo in reducing breathlessness was found. The subgroup analysis failed to show a positive effect of nebulized opioids on the sensation of breathlessness. Evidence supports the use of oral and parenteral opioids to treat dyspnea and argues against the use of nebulized opioids.

All but one study had a small sample size (n = 6–18 subjects); cancer-related dyspnea was included but was not a main focus of the research.

To compare a home-based exercise program plus standard lymphedema self-care with self-care alone in the management of breast cancer-related lymphedema

Women were randomly assigned to self-care alone or self-care plus exercise groups. Self-care consisted of compression hosiery, skin care, and general activity. Regular hand pumping during any activity involving a closed handgrip was included as standard care. The exercise program combined a series of gravity resistive isotonic arm exercises in a specific sequence to simulate manual lymphatic drainage. Patients were assessed at baseline and at 4,12, and 26 weeks. Patients were instructed to do exercises taught daily for 10–15 minutes and provided pictures and written directions for the exercises.

• N  = 23      
• MEAN AGE =65
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS:  Patients' duration of lymphedema ranged from 32–146 months.

• SITE: Single site  
• SETTING TYPE: Home   
• LOCATION: United Kingdon

• PHASE OF CARE: Late effects and survivorship

• Randomized, controlled trial

• Adherence to regimen evaluated via self report to open ended questions
• Limb volume measurement with perometer optoelectronic measure
• QuickDASH-9 questionnaire
• Range of shoulder motion measured with goniometer

Out of 85 potential participants, only 23 consented to participate. Analysis showed significant arm volume reduction in the intervention group, no significant reduction in the control group, and no significant arm volume changes between groups by the end of the study. There was no improvement in quality of life or range of motion. Both groups reported high adherence to usual self care measures. Fifty-five percent of the intervention group reported adherence to daily exercise use.

The exercise intervention appeared to have a positive effect in terms of limb volume lymphedema reduction. The study sample was likely too small to detect significant differences between groups at the end of the study.  Adherence to the exercise regimen was moderate.

• Small sample (< 30)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Questionable protocol fidelity
• Other limitations/explanation: The intervention group had lower severity of lymphedema at baseline. Authors state they excluded patients with a history of non-adherence, but even with this exclusion only slightly more than half of those assigned to the exercise intervention used it consistently.

Findings suggest that the exercise intervention used here in combination with standard lymphedema self-care may be beneficial in reducing arm lymphedema. This group of patients had long standing lymphedema, which can be more difficult to impact, so the approach may have promise. Findings suggest, however, that not a lot of patients wanted to participate in this, and that only about half actually completed the exercise as prescribed. Findings point to the challenge of maintaining patient adherence to such regimens and the need to develop effective strategies to support and facilitate patient adherence.