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.

To treat breast cancer-related lymphedema based on clinical audit results

Clinical audit of effective and ineffective treatment programs Inform the decision-making process regarding focus of care and funding efforts. The study surveyed three years of treatment data on onset and duration of swelling, severity (size and extent), lymphedema treatment received, and changes in severity over time. of 2,486 treatment sessions, 65% (1608) were manual lymph drainage (MLD) optimal intensive offered to all with moderate to severe lymphedema. Only 19 patients were willing to commit to the program. This was followed by MLD and compression garments. All patients with moderate to severe lymphedema were taught daily skin care, exercise, 

• Of the patients at London Haven, 268 patients were eligible.
• Patients were excluded if they had advanced disease or bilateral lymphedema.
• Ninety-five patients declined treatment.
• The sample was comprised of 168 patients.
• Seventy-four (44%) had follow-up data for 12 months for analysis.

The study took place at London Haven.

• Severity of swelling at first presentation measured by perometer excess limb volume (percentage excess limb volume [ELV])
• ELV mild swelling was less than 20%, ELV moderate 20%-40%, and ELV severe more than 40%.
• Breast and trunk swelling clinically determined by observation and palpation and patient report. 

Of patients with mild, uncomplicated lymphedema, 75% (39/52) received standard self-care regimen of hosiery, exercise, and skin care. Those patients had a mean reduction of 30% ELV was achieved by 13 patients for whom 12-month data were available. Thirteen (25%) received a short course of MLD (six sessions over two weeks). Mean reduction was 20% ELV, which is less than that achieved by self-care measures alone. Some patients in self-care group had stopped wearing their hosiery because at three and six months they had such improvement. Thirty-nine patients presented with breast or trunk edema and were treated with MLD and also taught self-massage. Of the 20 patients for whom 12-month data were available, 14 had complete resolution of edema. Moderate-to-severe lymphedema Intensive therapy was offered to 77 patients. Only 19 (25%) underwent one or more courses of intensive therapy. Twelve-month data was available on only 16 patients. At 12 months, swelling had reduced by 40% and six patients had little or no remaining edema. For those patients unable to do intensive therapy, mean reduction was 25%.

Breast edema treatment showed most improvement with MLD, self-care

• The results are based on cohort, observational data.
• The study only reflects the experience of one institution. 
• Costs of intensive therapy in terms of time, finances, and access were not fully addressed.

The audit reinforced the need for programs to offer full-service intensive therapy for patients with moderate to severe lymphedema. For patients unable or unwilling to commit to multilayer bandaging, MLD and self-care hosiery provided 25% reduction in ELV and warrants further investigation. Early treatment is advocated because almost 60% of patients developed symptoms within the first year postsurgery; only half had sought assistance from a lymphedema specialist within three months of onset of symptoms.

• FINAL NUMBER STUDIES INCLUDED = 2 
• TOTAL PATIENTS INCLUDED IN REVIEW = 22
• KEY SAMPLE CHARACTERISTICS: Various types of cancer, primarily lung cancer; study 1 age range was 63–80 years, study 2 mean age was 66 years

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

In the two studies included in this review, neither study showed any benefit to nebulized furosemide for dyspnea when compared to controls. Both studies used different doses of nebulized furosemide. Neither study reported adverse effects.

Nebulized furosemide was not beneficial for the relief of dyspnea in patients with cancer.

• Only included two studies
• Sample size was extremely small
• Measured outcomes varied significantly between studies
• Different doses of nebulized furosemide were used in each study
• High attrition rates in included studies
• Difficulty recruiting reported for included studies

Many patients with cancer experience feelings of dyspnea. Nurses should assess patients for the underlying causes of dyspnea and use appropriate interventions to treat these causes. In both intervention studies and in systematic reviews, nebulized furosemide has not been shown to be beneficial for patients with cancer who experience dyspnea.

To examine the effect of modafinil on patient-reported fatigue in patients with cancer who were undergoing chemotherapy.

Assessments were conducted at baseline after randomization and shortly after cycle two of therapy. Modafinil or placebo was started at 100 mg on day 10 or day five of study cycle two, then increased to a full dose of 200 mg after three days. This regimen then was continued until day seven of treatment cycle four, at which time all patients discontinued medication.

• A total of 877 participants were enrolled, and 631 were analyzed.
• Mean ages for the study groups were 60 and 61 years (range 18–90), and 66% to 68% were female.
• The most common sites were gastrointestinal, breast, and lung. The sample also included genitourinary, gynecologic, hematologic, and other cancers.
• Participants were required to be beginning a cancer treatment course of at least four planned cycles of chemotherapy with at least two weeks apart, with no concurrent radiation or interferon treatment.
• Patients were excluded if they had taken modafinil or any psychostimulant within the past 30 days.
• Participants had at least a score of 2 on the Brief Fatigue Inventory (BFI) question 3 (worst level of fatigue).
• Of the patients, 57% had received prior chemotherapy, and 22% to 24% had received prior radiation therapy.
• Most (67%–70%) participants were married, and about half had some college education.

This multisite study was set in 23 geographical areas across the United States among University of Rochester Cancer Center Community Clinical Oncology Program (URCC CCOP) affiliates.

This was a randomized, placebo-controlled, double-blind trial.

• BFI, question 3
• Epworth Sleepiness Scale (ESS) to measure excessive daytime sleepiness
• Profile of Mood States depression subscale (POMS-DD)
• Missing scores at cycle four were replaced with scores from cycle three for those who completed the study and only had evaluable data through cycle three (n = 58 for modafinil; n = 29 for placebo).

ANCOVA for BFI fatigue score showed an interaction between treatment effects and baseline BFI score (p = 0.017). A significant difference existed between the study groups for those who had severe fatigue at baseline (BFI of 7 or greater), with average score in the modafinil group. No differences in fatigue were observed between the study groups for those who had mild or moderate baseline fatigue. Daytime sleepiness on ESS showed significant improvement in the modafinil group (p = 0.002). No significant differences existed in depression outcomes between the groups. In the modafinil group, 11% of patients experienced adverse events, and in the placebo group, 9% had adverse events. Only three adverse events were judged to be definitely associated with treatment with modafinil: allergic reaction, dyspnea, and headaches.

The findings supported the use of 200 mg of modafinil as an effective treatment for severe cancer-related fatigue in patients undergoing chemotherapy. Modfinil was not effective for patients with less severe fatigue.

• It is not clear what the statistical effect was of the replacement of missing cycle four data with data from cycle three. The authors analyzed multiple data replacements to test this and found no differences. This suggests that the time frames of the study measures were irrelevant.
• The study demonstrated effectiveness for the short term during active treatment with only chemotherapy; the findings may not be the same for other groups of patients or other time frames of observation.
• Diversity of the sample in terms of racial and some other demographic findings was limited.
• Although no significant differences existed between study groups that would have affected the study results, the findings may not be applicable to other patients with different demographic characteristics.

To evaluate the effect of honey and 0.15% benzydamine hydrochloride on the onset and severity of radiation mucositis when compared to 0.9% normal saline

• Patients in group I were instructed to rinse their mouths and swish 20 mL of honey for 5 minutes and slowly swallow. This was to be done 15 minutes before, 15 minutes during, and 6 hours following radiation therapy (RT).
• Group II was instructed to rinse and then spit with 15 mL of 0.15% benzydamine hydrochloride for 5 minutes. This was to be done 15 minutes before, 15 minutes during, and 6 hours following RT.
• Group III (control group) was instructed to rinse with 20 mL of 0.9% normal saline for five minutes and then spit. This was to be done 15 minutes before, 15 minutes during, and 6 hours following RT.  
• The clinical grading of mucositis followed the World Health Organization (WHO) mucositis grading scale on day 1 of RT, daily during treatment, and weekly for two weeks following completion of RT.

• The study reported on 60 patients with an age range of 49–55 years.
• The sample was 70% male and 30% female.
• All patients had oral malignancies and were being treated with RT.

This was a single site, outpatient study conducted in Chennai, India.

Patients were undergoing the active antitumor treatment phase of care.

 This was a three-group, randomized, controlled trial.

Patients were assess via clinical exam.

The onset of mucositis and progression to grades 2, 3, and 4 were noted for each group. Group I had a later onset of grades 1, 2, 3, and 4 mucositis compared to Groups II and III. The difference was statistically significant (p < 0.001).

Honey can be an effective agent in managing radiation-induced oral mucositis. It is simple, inexpensive, and readily available. Further randomized studies are essential to validate the findings.

• The sample size was small with fewer than 100 patients.
• A risk of bias exists because of the lack of blinding.
• A risk of bias exists because of the variations in sample characteristics. For example, the duration of RT varied from 6000-7000 centiGray, and this variation was explained by time not the total dose. The authors did not describe if this difference between groups was statistically significant.
• Although the authors acknowledged that the intensity of mucositis can be altered by fractionation schedules, concurrent chemoradiotherapy, and comorbid medical conditions, including bacterial colonization of the oral mucosa, the study did not address these variables.
• The authors did not discuss how well the patients tolerated the honey.
• Subject withdrawal was not addressed. 
• Pain measurement was not addressed.

Mucositis during RT for oral malignancy is a continuing challenge for patients. Further testing of honey is needed. The availability and cost are benefits. The treatment is not complex or impractical.

To attempt to confirm the benefit of the antibiotic tetracycline in decreasing the severity of epidermal growth factor receptor (EGFR)–inhibitor-induced rash.

Eligible patients who were starting an EGFR inhibitor and were rash free were randomly assigned to tetracycline 500 mg orally BID for 28 days, versus placebo. Rash development and severity, quality of life, and adverse events were monitored during the four-week intervention and for an additional four weeks. The primary objective was to compare the incidence of grade 2 or worse rash between the study arms.

• The study reported on a sample of 65 patients aged 18 years or older.
• The sample was 63% male and 36% female.
• All patients had a cancer diagnosis and were starting an EGFR inhibitor.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, placebo-controlled clinical trial.

• Patients were monitored for rash severity by physician report using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.   
• Patient-reported questionnaire regarding rash
• Patient-reported quality of life as per the Skindex-16 questionnaire
• Patient-reported series of linear analogue self-assessment (LASA) scales
• Adverse events reported by the patient and physician
• Patient diary regarding compliance with EGFR inhibitor consumption

• The cumulative incidence of grade 2 or worse rash was comparable across study arms.
• Quality of life also was not significantly different between study arms.

This randomized, double-blinded, placebo-controlled study did not find that tetracycline decreased rash incidence or severity in patients who were taking EGFR inhibitors.

The sample size was small (fewer than 100 patients).

Quality of life was comparable and tetracycline was well tolerated, but the current results did not support what prior studies had suggested.

To compare the effectiveness of tetracycline 500 mg orally BID versus placebo for 28 days starting on day 1 of treatment with any epidermal growth factor receptor–inhibitor (EGFRI) agent to prevent or reduce EGFRI-induced rash in patients with cancer.

Patients were randomized to either the tetracycline arm (500 mg orally BID for 28 days) or the placebo arm.

• The study reported on a sample of 61 adult men and women with cancer.
• Thirty-one patients were randomized to the tetracycline arm, and 30 patients were randomized to the placebo arm.
• Median patient age was 71 years in the tetracycline arm and 63 years in the placebo arm.

This study was a collaborative effort of the North Central Cancer Treatment Group (including centers in Illinois, Iowa, Kansas, South Dakota, and Ohio) and the Mayo Clinic (Rochester, MN).

This was a placebo-controlled, doubled-blind trial.

Three patient-reported assessments were used.

• A brief rash incidence questionnaire
• SKINDEX-16 questionnaire relevant to rash development and its implications on patients' quality of life (this tool was previously validated)
• Questionnaire regarding patient compliance with EGFRI therapy

Those three questionnaires were completed at baseline and weekly for eight weeks after initiation of tetracycline or placebo. Oncologists performed an evaluation at the end of four weeks and eight weeks. The evaluation included a history and physical examination, an assessment of patient performance status, and an assessment of adverse events (e.g., gastrointestinal toxicity, rash development) as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

• At week 4, 70% of patients in the tetracycline arm (n = 16) and 76% of patients in the placebo arm (n = 22) developed a rash (p = 0.61).
• At week 8, 87% of patients in the tetracycline arm (n = 13) and 84% of patients in the placebo arm (n = 16) developed a rash (p = 0.84).
• By week 4, physician-reported grade 2 rash or rash covering more than 50% of body surface area (BSA) occurred in 17% of patients in the tetracycline arm (n = 4) and 55% of patients in the placebo arm (n = 16) (p = 0.04).
• By week 8, when 44% of the cohort had dropped out, physician-reported grade 2 rash or rash covering more than 50% of BSA occurred in 27% of patients in the tetracycline arm (n = 4) and 47% of patients in the placebo arm (n = 9) (p = 0.5).
• Of note, the worst physician reported rash (grade 3) occurred in one patient in the tetracycline arm.
• Results of the SKINDEX-16 questionnaire did not demonstrate uniform, statistically significant differences, with a few exceptions. Tetracycline exerted positive effects on quality of life in four questions (skin itching, skin burning or stinging, skin irritation, and being bothered by a persistence or recurrence of the skin condition). Tetracycline exerted a negative effect on one question (bothered about being annoyed about your skin). No statistical significance was found for the remaining 11 questions.
• Tetracycline was well tolerated with no significant difference in adverse events between study arms.

Administration of tetracycline prophylactically did not significantly affect the incidence of rash development in patients receiving EGFRI drugs. Indicators suggest administration of tetracycline prophylactically may have a favorable influence with regard to rash severity in patients receiving EGFRI drugs. In addition, the results suggested these rashes bother patients, who must contend with itching, burning, and other types of skin irritation.

• The sample size was relatively small.
• The measurement method for clinician grading of rash symptoms was not described.
• Six patients, including three patients from each study arm, stopped taking EGFRI medication within the first month because of the development of skin rash.