To determine whether the transdermal opioids transdermal fentanyl (TDF) or transdermal buprenorphine (TDB) or oral sustained-release hydromorphone (OSRH) produced different gastrointestinal side effects.

Patients with nociceptive pain receiving one of the study drugs (TDF, TDB, or OSRH) over four weeks at a stable dose were identified. Medication adherence was checked daily.

• The study reported on a sample of 174 patients.
• Mean patient age was 64.1 years (SD =11.6) in the TDF group, 65.3 years (SD = 10.7) in the TDB group, and 67.8 years (SD = 11.2) in the OSRH group.
• The sample comprised 27 women and 28 men in the TDF group, 25 women and 36 men in the TDB group, and 24 women and 34 men in the OSRH group.
• Patients were experiencing cancer-related pain.

• Single site
• Outpatient
• Germany

Not applicable

This was a prospective, open-label, controlled study.

• Eastern Cooperative Oncology Group (ECOG) performance status
• Selected European Organization for Research and Treatment of Cancer (EORTC) questionnaire items to assess constipation
• Numeric Rating Scale (NRS)
• Medications
• Physical assessments daily for five days

• No difference existed between the groups in mean intensity scores for constipation.
• Patients in the TDF group experienced slightly more constipation.
• No difference existed between groups in laxative use.
• TD narcotics caused more constipation than oral medication in this study.

TD narcotics caused more constipation than oral hydromorphone.

• The study lacked an appropriate control group.
• Although this study disclosed the types of laxatives used, it did not differentiate whether one substance could have been more beneficial than another.

In this study, TD narcotics caused more constipation than the oral narcotic.

To determine whether variable effectiveness exists in the use of polyethylene glycol (PEG), sodium picosulphate (SPS), and lactulose in ambulatory outpatients with cancer on opioid therapy.

Eligible patients were assigned to three treatment groups. A fourth group comprised patients who had discontinued laxative therapy (NL). Laxative groups were treated for a minimum of 28 days prior to data collection with mu agonist and assigned laxative. Prescribers were free to choose the laxative. The standard doses were PEG 13.1 g per day, SPS 10 mg per day, and lactulose 10 g per day. An increase in dose was allowed if participants were directed to do so by the prescriber.

During the five-day data collection phase, investigators assessed participants daily on mobility and pain assessment. Constipation was assessed by documentation of defecation rates, number of participants with lack of bowel movement for more than 72 hours, subjective intensity of constipation using a numeric scale, and consumption of laxatives.

Average defecation rate of all patients was calculated as defecations per patient per five days. The number of patients reporting nausea or emesis also was documented. The daily doses of the original opioid (oral morphine, hydromorphone, oxycodone, tramadol, or transdermal fentanyl) were transferred into morphine equivalent doses for uniform comparison.

• The study reported on a sample of 348 patients.
• Mean patient age was 62.4 years in the PEG group, 62.2 years in the SPS group, 65.6 years in the lactulose group, and 58.3 years in the NL group.
• Demographic and medical data were similar in all groups.
• The sample was 60% male and 40% female.
• Key disease characteristics were cancer-related pain, opioid therapy with mu agonists (equivalent doses of oral morphine, hydromorphone, oxycodone, tramadol, or transdermal fentanyl), ambulatory treatment, patient cooperation, and Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3.
• Patients were excluded from the study if they had used opioid antagonists, been referred for nonambulatory treatment, diarrhea at the beginning of therapy, disease likely to cause diarrhea (e.g., pancreatic cancer), opioid dose variations, conditions linked to opioid dose variations (e.g., breakthrough pain), communication deficits, hepatic or renal impairment, current chemotherapy or radiation therapy, nonambulatory status, terminal stage of disease, infection, prior history of drug or alcohol addiction or abuse, concurrent treatment with laxatives other than study medication, used more than a single laxative, partial agonists, and antagonist/agonist combinations.

• Single site
• Outpatient
• Pain Clinic, University Hospital, Bonn, Germany

• Patients were undergoing chronic pain management for cancer diagnoses.
• The study has clinical applicability for palliative care.
   

This was a controlled, prospective, open-label study.

• ECOG Performance Status for mobility
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for pain assessment
• Constipation Assessment Tool
• Numerical Rating Scale (NRS) for constipation and pain

• No patients in the study discontinued opioid therapy.
• NRS values for pain were comparable in all groups.
• After 28 days, PEG was the most frequently used laxative (n = 95, 27.3%) compared to SPS (n = 36, 10.3%) and lactulose (n = 32, 9.2%).
• Fifty-three percent of patients (n = 185) discontinued laxative therapy.

In this prospective study, PEG was more frequently prescribed than SPS and lactulose. However, the data did not prove the superiority of PEG over SPS and lactulose for the management of constipation in ambulatory patients with cancer on opioid therapy.

• The study took place at a single site and may be biased in that respect.
• No data exist to support whether opioid-induced constipation is dose-related or substance-related.
• Daily opioid doses in study groups differed significantly (p = 0.011).
• Medications were not blinded.
• Physician preference of PEG over SPS and lactulose may show bias.
• Some antiemetics used may have constipating effects.

No recommendation can be made.

To evaluate the therapeutic value of exercise to control or reduce nausea in patients with breast cancer receiving chemotherapy

Subjects were randomized to one of three groups.

• The experimental exercise group participated in a 10-week supervised program with a cycle ergometer and aerobic and interval training three times per week.
• In the placebo group, subjects met with exercise leaders on a weekly basis for conversational interaction and the mild stretching and flexibility exercises, which the experimental group also had performed during warm-up and cool down.
• The control group received no treatment, but patients were instructed to continue normal activities and notify study personnel if they began exercising.

• The study consisted of 42 women with breast cancer.
• The mean age of patients was 46 years.
• No race or ethnicity data were recorded.
• All patients were receiving chemotherapy (no doxorubicin), had had surgical treatment (mastectomy or lumpectomy), did not have uncontrolled cardiac disease or hypertension, were within the first six months of chemotherapy, and had had three treatments before entering the program.
• Functional capacity at baseline was 0-2 Zubrod score or Karnofsky Performance Status of 60%–100%.
• No participants were in an exercise program, and all were medically cleared by an oncologist.

• Participants were from a large Midwestern city.
• Patients were recruited from outpatient clinics, private practices, and a university medical center.

The design was randomized, with three groups and pre- and post-test measures.

Pretest to post-test nausea responses were coded as improved, no change, or worsened as reported on the Derogatis Symptom Checklist-90-Revised, a 5-point distress/somatization scale. This somatization scale has 12 items and includes a variety of symptoms common to medical patients.

The differences among the experimental, control, and placebo groups were statistically significant, with the experimental group showing marked improvement in nausea compared to the control and placebo groups. The experimental group showed significant improvements in the Somatization scale scores (i.e., perceptions of autonomically mediated symptoms) over the control and placebo groups.

• The study was restricted to women with breast cancer who were on a specific aerobic exercise protocol; therefore, the study is not generalizable to other groups with cancer.
• One cannot assume that other exercise techniques will generate the same results.
• Patients with a history of hypertension or cardiac disease were excluded.
• No patients receiving doxorubicin were admitted into the study.
• Exercise testing was monitored by a physician.

Moderate aerobic exercise may provide some benefit in reducing nausea. Researchers recommended that patients abstain from exercise several hours prior to blood testing and on days of treatment.

To evaluate fluconazole versus voriconazole in terms of fungal-free survival (FFS) (i.e., alive and free from proven, probable, or presumptive invasive fungal infection [IFI]) at 180 days posttransplant.

Patients who met the eligibility criteria were randomly assigned to receive voriconazole 200 mg twice daily or fluconazole 400 mg once daily before transplantation.  To maintain the blind, placebo was administered to match the number of doses for the two arms.  Study drugs were continued from days 0 until 100 posttransplantation.  Premature withdrawal of study drug was mandated for the occurrence of documentation of IFI, grade 3 or 4 toxicity, or relapse of underlying disease.

• Six hundred patients were included (295 in the fluconazole arm [55% male, 45% female] and 305 in the voriconazole arm [56% male, 44% female]).
• Median age for both groups was 43 years.
• Two hundred thirty-four (78%) patients had acute myeloid leukemia (AML), 122 (41%) had acute lymphoblastic leukemia, 103 (34%) had chronic myelogenous leukemia, 98 (33%) had myelodysplastic syndrome, and 43 (14%) had non-Hodgkin lymphoma.
• Human leukocyte antigen matched 6/6 encompassed 96% of patients, and the remaining 4% being 5/6 matches.

• Mutli-site  
• Thirty-five centers participated in the Blood and Marrow Transplant Clinical Trials Network.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, multi-center study.

• Routine galactomannan testing on serum samples were collected twice weekly through day 60 and once weekly through day 100.    
• Computed tomography scans were obtained.
• Bronchoalveolar lavage/biopsies were performed.

By 180 days after hematopoietic cell transplant (HCT), 55 patients had developed IFIs (14 proven, 24 probable, and 17 presumptive), and by one year after HCT, 79 patients had developed IFIs (28 proven, 33 probable, and 18 presumptive). Aspergillus was the most frequent pathogen, accounting for 26 (47%) and 38 (48%) IFIs at days 180 and 365, respectively.  Cumulative incident rates of IFIs were 11.2% and 7.3% for fluconazole and voriconazole, respectively, at 180 days and 13.7% and 12.75%, respectively, at 356 days.  At 180 days, there was a trend toward fever and Aspergillus spp. infections in the voriconazole arm, but no difference existed in the rates of other IFIs, including those caused by Zygomycetes. Fungal-free survival rates were similar at 180 days:  75% and 78% for fluconazole versus voriconazole, respectively, and 65% and 64%, respectively, at 365 days. There was no difference in overall survival at 180 days or 365 days between the two groups. Toxicity was similar between the two arms. There were no significant differences in study outcomes between the groups.  Significant predictors of IFIs in both groups were a diagnosis of AML and age >18 and grade 2–4 graft-versus-host disease among those at high risk.

There were no differences in fungal infection-related outcomes between patients receiving fluconazole or voriconazole.

• Enrollment was limited to patients who were not at high risk for early death or relapse.
• Patients who had little or excessive risks for IFI or death were excluded.
• The patient population was selective.

Data indicated that there was no difference in FFS at 6 months between the voriconazole and fluconazole arms in intensive monitoring and early intervention in standard-risk HCT patients.  However, it is unclear if this would be true in patients who are not intensively monitored and/or at higher risk of IFI.  Further studies are needed to optimize outcomes in higher-risk groups.

The primary aim was patient evaluation of the usefulness of information provided. The secondary aim was to assess whether patients reported exercising during cancer treatment.

Patients starting a course of radiotherapy or chemotherapy (inpatient and outpatient) at Tayside Cancer Centre in the United Kingdom were given a “Fatigue Initiative” folder containing information on fatigue combined with advice on starting aerobic walking exercise during treatment. Patients were also encouraged to attend workshops on fatigue management as listed on flyers in the folder. Materials included home exercise information, walking information, and a guide for good sleep.

• In total, 146 patients (90 females, 115 males) were included. 
• Mean age was 63.4 years. 
• Patients had genitourinary (n = 119), gynecologic (n = 37), breast (n = 46), and other (n = 3) cancers.
• There were four treatment groups:  radical radiotherapy, postoperative radiotherapy, palliative radiotherapy, and chemotherapy.

United Kingdom

This was an observational cohort study.

• The Brief Fatigue Inventory (BFI) was used to assess level of fatigue before and after cancer treatment. The tool was administered four times:  at baseline, end of treatment, and the first and second follow-up visits. 
• Two study evaluation questionnaires were used:  one rated information usefulness and one provided information regarding exercise. No questions or scores were provided.

Overall, patients reported an increase in fatigue from baseline to the end of cancer treatment and from baseline to the first follow-up. Of the patients, 70% to 78% rated the information on fatigue helpful. Patients who said they used the information were more likely to exercise (odds ratio [OR] = 3.71; 95% confidence interval [CI] [1.19, 11.56]; p = 0.024). Patients who received radiotherapy were more likely to exercise than those receiving chemotherapy (OR = 14.9; 95% CI [2.43, 81.53]; p = 0.003). Higher levels of fatigue were reported by patients who used the information provided. Patients who exercised (p < 0.001), were older (p = 0.001), had other than breast cancer (p = 0.018), and who were not receiving chemotherapy (p < 0.05) reported lower fatigue scores on the BFI. Ten patients participated in a fatigue workshop.

Findings supported the positive effect of exercise on fatigue during cancer treatment and identified that age, breast cancer, and treatment with chemotherapy rather than radiotherapy were associated with the level of fatigue experienced. Findings suggested that the provision of written educational/informational materials can be helpful in encouraging patients to exercise.

• No appropriate control group was used.
• Time intervals varied between baseline and end of treatment for those receiving palliative radiotherapy (one to two weeks), radical or postoperative radiotherapy (four weeks), or chemotherapy (four months).
• Workshops were held in palliative care centers.

Fatigue did not decrease in any group. The study demonstrated the importance of providing information on fatigue encouraging a walking/home exercise program. Patients who were able to exercise during treatment had lower fatigue levels. The finding that those who used the information had higher levels of fatigue may suggest that patients who have the most fatigue are more likely to use information to help them cope with it.

For patients to evaluate the usefulness of the information provided.

Patients starting a course of radiotherapy or chemotherapy (inpatient and outpatient) at Tayside Cancer Centre in the United Kingdom were given a “Fatigue Initiative” folder containing information on fatigue together with advice on starting aerobic walking exercise during treatment. Patients were also encouraged to attend workshops on fatigue management as listed on flyers included in the folder. Materials included home exercise information, walking information, and a guide for good sleep.

• The sample was comprised of 146 patients (90 women and 115 men). 
• Mean age was 63.4 years.
• Patients had genitourinary (n = 119), gynecologic (n = 37), breast (n = 46), and other (n = 3) cancers.
• The study included four treatment groups:  radical radiotherapy, postoperative radiotherapy, palliative radiotherapy, and chemotherapy.

• Single site
• United Kingdom

This was an observational cohort study.

• Brief Fatigue Inventory (BFI) to assess level of fatigue before and after cancer treatment. The tool was administered four times:  baseline, end of treatment, and the first and second follow-up visits.
• Two study evaluation questionnaires were used:  one rated the information usefulness, and one provided information regarding exercise. No questions or scores were provided.

Overall, patients reported an increase in fatigue from baseline to the end of cancer treatment and from baseline to the first follow-up visit. Of the patients, 70% to 78% rated the information on fatigue helpful. Patients who said they used the information were more likely to exercise (odds ratio [OR] 3.71; 95% confidence interval [CI] [1.19, 11.56]; p = 0.024). Patients who received radiotherapy were more likely to exercise than those receiving chemotherapy (OR 14.9; 95% CI [2.43, 81.53]; p = 0.003). Higher levels of fatigue were reported by patients who used the information provided. Patients who exercised (p < 0.001), were older (p = 0.001), had cancers other than breast (p = 0.018), and were not receiving chemotherapy (p < 0.05) reported lower fatigue scores on the BFI. Ten patients participated in a fatigue workshop.

The findings supported the positive effect of exercise on fatigue during cancer treatment and identified that age, breast cancer, and treatment with chemotherapy rather than radiotherapy are associated with the level of fatigue experienced. The findings suggest that the provision of written educational/informational materials can be helpful in encouraging patients to exercise.

• The study lacked an appropriate control group.
• Time intervals varied between baseline and end of treatment for those receiving palliative radiotherapy (one to two weeks), radical or postoperative radiotherapy (four weeks), and chemotherapy (four months). Workshops were held in palliative care centers.

Fatigue did not decrease in any group. The study demonstrated the importance of providing information on fatigue and encouraging a walking/home exercise program. Patients who were able to exercise during treatment had lower fatigue levels. The finding that those who used the information had higher levels of fatigue may suggest that patients who have the most fatigue are more likely to use information to help them cope with it.

To systemically evaluate the evidence regarding the effectiveness of mindfulness-based stress reduction (MBSR) for sleep disturbance.

Databases searched were MEDLINE, AMED, CINAHL, PsycINFO, The Cochrane Central Register of Controlled Trials, and Digital Dissertations.

Search keywords were mindfulness-based stress reduction, meditation, mindfulness, sleep, and insomnia. The terms mind-body relations and mind-body relaxation techniques were searched in combination with sleep and insomnia. The Cochrane Central Register was searched using the keywords meditation and sleep.

Studies were included if they

• Were clinical trials, systematic reviews, or meta-analyses
• Were published in the English language
• Used MBSR (including several forms of meditation techniques) with multiple treatment sessions and pre- and postintervention assessment of sleep quality and duration.

Studies were excluded if they investigated only one of several modalities of MBSR provided to a treatment group or reported only qualitative outcomes.
 

• In total, 38 references were retrieved.
• The first and second author identified and reviewed potentially relevant articles. When necessary, the authors of excluded articles were contacted to confirm nonuse of MBSR interventions.
• No specific method for evaluating study quality was described.

• The final number of studies included was seven.
• The total sample included 423 participants.
• The sample range across studies was 16 to 115 participants.
• In all studies included, at least 50% of the participants were women.
• Seventy-six percent of all participants had at least one medical and one mental health diagnosis.
• Mean age ranged from 46 to 57 years. 
• Studies were conducted in patients with cancer (n = 3), patients on sleep medicine (n = 1), patients with fibromyalgia (n = 1), solid organ transplant recipients (n = 1), and patients seen at a community health center (n = 1).
• All MBSR interventions lasted 8 to 10 weeks and included formal home practice.

Outcome measures included the Pittsburgh Sleep Quality Index (PSQI), sleep diaries, visual analog assessment of sleep quality, and self-reports. Four studies found significant differences in sleep quality from pre- to postintervention. Both studies with control or comparison groups showed no significant differences in sleep quality from pre- to postintervention.  One study that included English- and Spanish-speaking participants demonstrated that English speakers showed more improved sleep quality than Spanish speakers. Two studies found significant differences in sleep quality related to home MBSR practice; however, one study found no significant differences related to practice time.

Given the very mixed results of the included studies, more research is needed to determine the impact of MBSR on sleep quality. Controlled studies that closely adhere to standardized MBSR interventions are necessary to fully describe the effects of MBSR on sleep quality. Comparisons between studies were limited due to the variability of sleep measures used. Studies using well-established and standardized measures of sleep quality are also needed.

• Only one study included a control group.
• Only one study on patients with cancer was included.

Given the mixed results seen and because only one study on patients with cancer was included, this review did not provide strong evidence of the efficacy of MBSR.

The purpose of the study was to assess the use of antimicrobial-coated sutures compared with conventional polyglactin and poliglecaprone for skin closure after breast cancer surgery for the reduction of surgical site infections.

Women diagnosed with breast cancer who were scheduled for primary elective surgery at a single center were approached for participation in the study. Following consent, they were block randomized in groups of 50 using random computer numbers. Sequential sealed envelopes were used and the type of suture to be used was revealed in the surgical suite just prior to surgery. The surgeon, patient, and assessor at follow-up were blinded. Following surgery, surgical sites were assessed at two weeks and six weeks using the Centers for Disease Control and Prevention (CDC) and ASEPSIS definitions for surgical site infections. In addition, patients completed a diary up to six weeks post-op, which included added details by the general practitioner and/or practice nurses. Other wound infection information also was gathered and included delays in radiotherapy or chemotherapy.

• The sample was comprised of 150 participants, all female, and all older than age 18.
• 75 participants were in each study arm
• Patients were included if they had breast cancer that was not inflammatory or did not have skin ulcerations.
• In addition to inflammatory breast cancer or skin ulcerations, patients were excluded if they received neo-adjuvant chemotherapy or radiotherapy, were having surgery for benign or reconstructive reasons, had known immune deficiency or allergy to triclosan, or were unable to give consent or appeared as if they were unlikely to comply with follow-up.

A single site (both inpatient and outpatient) in Wales

Active treatment

Randomized, controlled trial; double-blinded

•  CDC criteria for surgical site infections 
•  ASEPSIS criteria for surgical site infections
•  Southampton wound scores
•  Demographics (age, weight, type of operation)
•  Patient diary
•  Document

The overall rate of surgical site infections was 18.9% at six weeks, with six patients needing an intervention or readmission for the infection. No statistically significant differences were found between types of sutures; however, use of the anti-microbial sutures did show less surgical site infections (15.2% in the anti-microbial group versus 22.9% in the control group).

Anti-microbial sutures may be beneficial in the reduction of surgical site infections in adult women with breast cancer. A larger study is needed to have enough power to show statistically significant differences.

Surgical site infections following breast cancer surgery is prevalent. Careful and frequent evaluation of the surgical site is highly important. Use of anti-microbial sutures may reduce infections.

A 20-minute audiotape was used that included education about the self-care behaviors of exercise and relaxation to manage anxiety, fatigue, and sleep problems. A self-care diary mirrored the audiotape. The control group received education about side effects. Outcomes were fatigue, anxiety, and sleep.

• The sample was comprised of 71 patients.
• Mean age was 50.4 years (range 30–74).
• Of the patients, 85% had stage I or II breast cancer and were receiving chemotherapy regimens with cyclophosphamide.

• Tertiary medical center and a satellite cancer treatment clinic
• Southeastern United States

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

A modified self-care diary measured the number of side effects, severity of each side effect, number of self-care behaviors performed for each side effect, and the effectiveness of each self-care behavior.

More women in the control group reported difficulty sleeping at baseline; both groups experienced increased severity of sleep disturbance between the first and second self-care diary.

• Control was lacking regarding how much and what kind of information was given to women at the time of treatment. The use of the self-care audiotapes may have been insufficient.
• The trial had a small sample size.

To determine if aloe vera gel can prevent the development of radiodermatitis in patients undergoing breast radiation therapy (RT).

In both studies, gels were applied twice a day starting within three days of RT initiation. Each patient received instruction on skin care. Patients were stratified by age groups:  younger than 45 years, 45 to 60 years, and older than 60 years.

• Study 1 included 194 patients.  
• Study 2 included 108 patients. 
• Patients were younger than 45 years (21.5%), 45 to 60 years (35%), or older than 60 years (43.5%). 
• All patients were women. 
• Patients had breast cancer.
• Patients were not receiving concomitant chemotherapy, and there were no scars or ulcers in the treatment field.

Two studies were reported:  a randomized, double-blind, controlled trial of aloe versus placebo gel and a randomized trial of aloe versus no treatment.

• Patients were rated by an MD/RN on scale of 0 (normal) to 3 (moist desquamation and/or ulceration).
• Patients self-rated on the same scale and completed questionnaires at the start and weekly until one month post RT. 
• Kaplan-Meier curves and log rank test were used to compare treatment arms.
• Severity scores were compared using Wilcoxon test.
• Spearman rank correlation coefficients were calculated to compare maximum severity.

• Study 1:  Mean severity score in aloe versus placebo gel was 1.9 and 1.9 by patient judgment. Mean severity score in aloe versus placebo gel was 1.5 versus 1.6 as judged by a healthcare provider. No significance was found.
• Study 2: Mean severity score in aloe versus no treatment was 1.9 versus 2 by patient judgment. Mean severity score in aloe versus no treatment was 1.7 versus 1.5 as judged by a healthcare provider. No significance was found.

The study does not support the hypothesis that aloe vera gel can decrease RT-induced dermatitis.

• The study lacked interrater reliability.
• The study did not use a valid or reliable scale.
• Patients were able to use other treatments, such as hydrocortisone or domeboro if they had skin problems, so it is not clear if confounding treatments were given.
• No skin care regimen log was used to determine adherence.