To assess the efficacy of mindfulness-based therapy on pain and distress in women treated for breast cancer

After completing baseline questionnaires, patients were randomized to the intervention or waitlist control group. The intervention was adapted from a standard intervention manual to the use of a shorter two-hour session, shorter meditation exercises, more gentle yoga exercises, and the elimination of all day sessions. The intervention was delivered in groups during eight consecutive weeks. All sessions were facilitated by a trained mindfulness instructor. Study measurements were conducted after the intervention and at three and six months after completion.

• N = 107  
• MEAN AGE = 56.4 years
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: All had breast cancer and the majority had surgery and radiotherapy; 72% were on endocrine therapy. The average time since surgery was 40.6 months.
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-four percent were married or cohabitating, and 45.2% were retired.

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

PHASE OF CARE: Transition phase after active treatment

Randomized, controlled trial with waitlist control

• Carlson Comorbidity Index
• Short-Form McGill Pain Questionnaire (SP-MPQ)
• Hospital Anxiety and Depression Scale (HADS)
• Report of pain medication use
• Adherence assessed by sessions attended and time spent on homework via self-report

Pain intensity and neuropathic pain declined over time in the intervention group compared to the control group (p = 0.036). No differences in anxiety or depression over time were reported between groups. The average number of sessions attended was five, and the average amount of time spent on homework was 24 minutes per day. A direct correlation between number of sessions attended (p = 0.01) and time spent on practice (p = 0.01) was reported. The dropout rate was 22% across both study groups; only four dropouts were in the control group.

Participation in the mindfulness-based intervention was associated with a reported reduction in pain intensity; however, a large percentage of those allocated to the intervention dropped out of the study or were lost to follow-up, suggesting that the intervention as provided may not be practical to many patients.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Intention to treat analysis may have overestimated effects—the intervention group had lower pain scores at baseline and had a large percentage of dropouts.

Mindfulness-based group therapy may be helpful in the management of long-term pain with breast cancer but was not shown to have an affect on anxiety or depression over time. The strength of findings in this study is limited because of study limitations.

To assess the efficacy and safety of lubiprostone 24 mcg BID in patients with chronic constipation.

Patients were randomized to receive either oral lubiprostone 24-mcg capsules or placebo capsules. Patients continued to record information regarding bowel movements (BMs), use of rescue medications, and symptoms on a daily basis. Study drug capsules were counted to assess compliance every two weeks. Rescue medication comprised bisacodyl suppository and fleet enema if the suppository was not effective. Efficacy was defined as the frequency of spontaneous BMs during the first and subsequent study weeks. Patients were followed for four weeks.

• The study reported on a sample of 224 patients.
• Mean patient age was 48 (SD = 12.28) to 49 years (SD = 12.93) across study groups.
• The sample was 89% female and 11% male.
• Patients were excluded if they had mechanical obstruction. No other diagnosis information was provided.

• Multi-site
• Outpatient
• Midwestern United States

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

• Four-point Likert-type scales for symptoms of bloating, straining, and discomfort; stool consistency; and global treatment effectiveness
• Patient diary

• Patients in the lubiprostone group reported significantly more spontaneous BMs than those in the control group (p = 0.0001) during the first and subsequent weeks.
• Fifty-seven percent of patients in the lubiprostone group experienced a spontaneous BM within 24 hours of taking the first dose compared to 37% in the placebo group (p = 0.0024).
• Use of rescue medication was significantly lower in the lubiprostone group ( p = 0.036).
• Patients in the lubiprostone group reported significant improvement in all related symptoms compared to those in the placebo group (p < 0.05).
• No significant differences existed between groups in reported events. The most frequent event was nausea. Eight percent of patients in the lubiprostone group were discontinued from the study because of adverse events including nausea, headache, flatulence, and diarrhea.

Taking lubiprostone improved frequency of spontaneous BMs and constipation-related symptoms, with low incidence of treatment-related adverse events.

• Patient diagnoses were not provided, and whether any patients had issues such as opioid-induced constipation is not known.
• Use of rescue medications was stated to decline, but actual use was not reported and the definition of primary treatment efficacy did not specify spontaneous BM without rescue medication.
• Applicability to patients with cancer is not clear.

Lubiprostone effectively improved constipation in this study; however, applicability to patients with cancer is not clear. Nausea was the most common side effect, which could limit its use in patients with cancer, who may be on other medications and treatments that also cause nausea. Research involving patients with cancer-related constipation should be considered.

To estimate the prevalence of pneumonia after tracheotomy in patients with head and neck cancer, and to evaluate the effect of prophylactic antibiotics

Data on patients who underwent tracheotomy were obtained from health records, and patients were grouped according to whether they had been given prophylactic antibiotics. In all cases, tracheotomy was the primary operation. The comparison of ventilator-associated pneumonia was analyzed.

• N = 88  
• MEAN AGE = 68.3 years (SD = 9.9)
• MALES: 69%, FEMALES: 31%
• KEY DISEASE CHARACTERISTICS: All had head and neck cancer, and 71% had prior radiation therapy.
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 88% had underwent a because of stridor. The median time from radiation to the procedure was 160 days.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Denmark

• PHASE OF CARE: Transition phase after active treatment

• Retrospective

Pneumonia was defined as the clinical suspicion of pneumonia or the postoperative administration of antibiotics.

More patients who did not receive prophylaxis received antibiotics postoperatively (p = 0.04). The hospital stays of those given prophylactic antibiotics were seven days shorter (p < 0.01).

Prophylactic antibiotic administration for patients undergoing tracheotomy may reduce the risk of postprocedure ventilator-associated pneumonia.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• No standard and objective measure of pneumonia

Prophylactic antibiotic use in patients undergoing surgical procedures has been shown to reduce postoperative infections. The findings from this study add to that body of evidence, suggesting that this approach prior to tracheostomy provides a similar benefit in preventing ventilator-associated pneumonia.

The article evaluated lipid-soluble formulations of amphotericin B compared with conventional amphotericin B.

The Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed (through November 2007) databases were searched, as were the proceedings from the Interscience Conference on Antimicrobial Agents and Chemotherapy (1990–2007), the General Meeting of the American Society of Microbiology (1990–2007), and European Congress of Clinical Microbiology and Infectious Diseases (1995–2007). In addition, the reference lists of articles were searched, and researchers in the field were contacted.

12 randomized trials

• 1,895 neutropenic patients with cancer.
• Most patients had acute leukemia or were undergoing hematopoietic stem cell transplantation (HSCT).

• Lipid-based amphotericin B was not more effective than conventional amphotericin B for mortality.
• Lipid-based amphotericin B decreased invasive fungal infections by 35%.
• Lipid-based amphotericin B decreased nephrotoxicity by 55%.
• Lipid-based amphotericin B decreased dropouts from the study by 22%.

There was no significant difference in mortality for the drug used in most patients, AmBisome (three trials, 1,149 patients), whereas it tended to be more effective than conventional amphotericin B for invasive fungal infection (RR = 0.63, 0.39 to 1.01, p = 0.053).

Despite a significant reduction in invasive fungal infections and nephrotoxicity seen with lipid-based amphotericin B formulations, the authors concluded that an advantage was unclear regarding the use of lipid-based amphotericin B formulations if conventional amphotericin B is administered under optimal circumstances.

In the trials reviewed, amphotericin B rarely was administered under optimal circumstances (routine premedication for the prevention of infusion-related toxicity and supplementation with fluid, potassium, and magnesium for the prevention of nephrotoxicity).

To examine fluconazole (oral or intravenous [IV]) compared with amphotericin B (oral or IV) in patients with cancer who were neutropenic.

Databases searched were The Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed (through November 2007).  The authors also searched the proceedings of the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) (1990–2007), the General Meeting of the American Society for Microbiology (ASM) (1990–2007), and the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) (1995–2007). In addition, the authors contacted researchers in the field and industry and reviewed reference lists to identify unpublished trials.

• Seventeen randomized, controlled trials were reviewed.
• The total number of participants was 3,798.
• The sample consisted of patients with cancer who were neutropenic.
• Most patients had acute leukemia or were undergoing hematopoietic stem cell transplantation.

No significant difference was found between fluconazole and amphotericin B with regard to

• Mortality
• Invasive fungal infection
• Colonization
• Use of rescue therapy
• Dropouts.

The major adverse effects were hepatic impairment and gastrointestinal adverse effects with fluconazole and infusion-related toxicity, renal impairment, and gastrointestinal adverse effects with amphotericin B.

Considerable heterogeneity existed in the studies, and amphotericin B was not favored in several of the largest trials through the trial design or data analysis.  Of particular concern was that seven trials compared oral fluconazole to oral amphotericin B. Oral amphotericin B is poorly absorbed and is not recommended for prophylaxis or the treatment of systemic fungal infections. No trial report offered a rationale for this design, and attempts by the authors to obtain additional information from the investigators were unsuccessful.

In the 10 trials that compared oral or IV fluconazole to IV amphotericin B, the design disfavored the amphotericin B arm. Clinicians familiar with the optimal administration of amphotericin B routinely prescribe premedication to prevent infusion-related toxicity and fluids (potassium and magnesium) to prevent nephrotoxicity. Supplemental fluids (i.e., potassium and magnesium) were not prescribed in any trial reviewed, and premedication was prescribed in only two trials. 

The majority of these trials were sponsored by the company that manufactured fluconazole, and the authors were unable to obtain additional information or access to certain trial data held by the company.

The authors concluded that there was not sufficient data from the available trials to judge the effectiveness of fluconazole compared with amphotericin B. Amphotericin B should be preferred because it is the only antifungal for which evidence suggests an effect on mortality.

STUDY PURPOSE: To systematically review and quantify research on the effect of psychosocial interventions on pain in patients with breast cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: Cochrane, PubMed, PsycINFO, EMBASE, Web of Science

KEYWORDS: breast cancer; pain; cancer-related pain; intervention; psychosocial; yoga; mindfulness; meditation; hypnosis; psycho-education; therapy

INCLUSION CRITERIA: Data on a psychosocial intervention; baseline and post-intervention pain measures; data on breast cancer populations; quantitative research

EXCLUSION CRITERIA: Patients younger than 18 years; non-English speaking; non-peer reviewed

TOTAL REFERENCES RETRIEVED = 163

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Independently reviewed by two raters who disagreed on 13 (8.7%); 0.71 kappa statistic for inter-rater agreement

• FINAL NUMBER STUDIES INCLUDED = 26
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,193 women; 1,786 in analysis
• KEY SAMPLE CHARACTERISTICS: Patients with stage I–IV breast cancer; majority had completed treatment
   

• PHASE OF CARE: Multiple phases of care     
• APPLICATIONS: Elder care, palliative care

Psychosocial interventions overall were found to be effective. Robust effect size was found (g = 0.37) [95% CI 0.2–0.4]) but was smaller (g = 0.21) when adjusted for publication bias. Patient education approaches yielded a larger effect (g = 0.64) than supportive group therapy (g = 0.17).

Psychosocial interventions are effective in reducing pain in patients with breast cancer. Patient education and supportive group therapy appear to be the most effective interventions.

• Quality of research papers varied.
• Pain was not the primary outcome in most studies.

Nurses should employ psychosocial interventions to help ameliorate pain in patients with breast cancer. Education and support group interventions should be used initially because they appear to yield the greatest benefit.

To evaluate the efficacy of optimizing hot flash (HF) treatment, as determined by sleep and quality of life (QOL) measurements, by combining the hypnotic agent zolpidem with a selective-serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) in a randomized, placebo-controlled, double-blind clinical trial.

All women were evaluated for current use of SSRIs/SNRIs for the treatment of HFs. If currently on an SSRI/SNRI for HFs, they were instructed to continue use. If they were nonusers, they were started on venlafaxine 75 mg per day. They were then randomized to receive zolpidem 10 mg each evening or placebo each evening for five weeks. Patients were evaluated at baseline and at the end of the study.

• The study enrolled 53 women with a mean age of 51.1 years (range 29.6–65.3 years).
• The women were being treated for breast cancer or were being managed for increased risk of breast cancer. 
• Adjuvant endocrine therapies were used by 71% of the women, with 29 taking tamoxifen.
• The level of perceived sleep disturbance was high.
• Patients reported HFs and awakenings, part of a clinical insomnia syndrome that was attributed to the HFs.
• Median time since diagnosis was 27.2 months (interquartile range 13.7–49.9 months).
• Patients must have completed therapy more than three months prior to enrollment.
• Menopause status varied.
• Women with primary sleep disorders or psychiatric disorders were excluded.

• Multisite
• Outpatient clinics
• Boston, Massachusetts

Patients were undergoing the long-term follow-up phase of care.

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

• Objective and subjective sleep HF measures:  sleep questionnaire, sleep diary, actigraphy using an actigraphic watch (Actiwatch-Score, Mini Mitter  Co, Inc. Bend, Oregon), skin temperature using the sterna lskin-conductance monitor (Biolog ambulatory recorder, UFI, Morro Bay, California), 7-day North Central Cancer Treatment Group Daily Vasomotor Symptom Diary    
• Beck Depression Inventory (BDI)
• Period of time awake after sleep onset (WASO) as determined by the actigraphic watch
• Pittsburgh Sleep Quality Index (PSQI)
• Quality of Life Inventory (QOLI)

Due to the high percentage of drop-outs in the placebo arm, the investigators changed the way they evaluated the results.  First, they identified the number of people who completed the study and showed improvement in sleep scores. The proportion of women completing the study varied by treatment assignment; 88% (22/25) of those who received zolpidem completed the therapy, whereas 57% (16/28) of those receiving placebo did so. Responders were those who completed the study AND showed improvement in their sleep scores. Forty percent (10) of the women taking zolpidem responded, whereas 14% (4) of the placebo group responded. Sleep improved in more women in the zolpidem arm than the placebo arm. The investigators looked at the differences in outcome measures between the two groups that completed the therapy. Measurements of PSQI scores and WASO time were significantly worse in the placebo arm. PSQI scores improved by 15% in the zolpidem arm and worsened by 26% in the placebo arm. The same was true with WASO time, which improved by 9% in the zolpidem arm and worsened by 2% in the placebo arm. In addition, patients in the zolpidem arm showed improvement in their QOL scores, whereas those on placebo showed a decrease in QOL scores. No change occurred in depressive symptoms in either group.

Zolpidem appears to improve a patient’s perception of nighttime HFs, perhaps by allowing her to sleep through the HF. Sleep scores improved, as did QOL in patients who augmented SSRIs with zolpidem for HFs. No change occurred in objective measurements of the number of HFs. Treatments targeting sleep may be an important supplemental strategy to optimize well-being.

• The study had a small sample size.
• The study had a high drop-out rate.
• The study had a heterogeneous sample.

Sleep disturbances due to HFs are among the most commonly reported symptoms in patients with breast cancer.  Augmenting SSRIs/SNRIs with zolpidem may improve perception of nighttime HFs and, in turn, improve sleep and QOL. Further study is required.

To investigate the efficacy and safety of vitamin K1 cream for cetuximab-associated acneiform rash

All participants in the research arm were given vitamin K1 (phytomenadione 0.1%, Reconval^® K1, manufactured by DRODERM^® in Slovenia) before initiating cetuximab therapy. A participant was to apply vitamin K1 to his or her face, anterior, and posterior trunk twice daily on day 1 and throughout therapy. Concomitant oral antibiotics were allowed for grades ≥ 2 acneiform rashes. Evaluation of compliance and observance of rashes took place at each clinic visit. The study population was compared to a historical control group that had received cetuximab-containing chemotherapy with or without oral antibiotics but without topical K1 cream. A dermatologist graded rash severity.

• N = 101
• AVERAGE AGE = 56.5 years
• MALES: 62% in study arm and 75% in control arm, FEMALES: 38% in study arm and 25% in control arm
• KEY DISEASE CHARACTERISTICS: Metastatic colorectal cancer with metastases to liver, lymph nodes, peritoneum, and/or lung. All patients were KRAS wild-type. 
• OTHER KEY SAMPLE CHARACTERISTICS: Study arm participants were ECOG 0–1, 93%, (> 2, 7%); control patients were 0–1 ECOG, 100%; no one in the study arm had received an EGFR inhibitor or had received topical or oral treatment for dermatologic reasons.

• SITE: Single-site  
• SETTING TYPE: Not specified  
• LOCATION: Asan Medical Center, Seoul, Korea

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

Non-randomized, open-label, interventional study with historical control

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI, CTCAE) v3.0 to grade rash severity

In the historical control, acneiform rash of any grade occurred in 97.5% of patients. In the experimental group, 88.5% of patients experienced any grade of rash. No significant difference was found between the groups. There was no significant difference between groups for the median time to rashes grades ≥ 1 or time to rashes grades ≥ 2. There was no significant difference in the overall occurrence of rashes grades ≥ 2 between the groups at any point. There was no significant difference in the time to improvement from grades ≥ 2 to grades ≥ 1 rashes.

Vitamin K1 is not an effective prophylactic treatment of acneiform rash associated with cetuximab treatment.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable
• Other limitations/explanation: Data do not support the comparison of results to any other disease sites also using cetuximab therapy. Non-randomized, non-blinded trial.

Nurses should be aware that using topical vitamin K1 for prophylaxis of cetuximab-associated acneiform rash is not an effective treatment. Other interventions should be considered for patients receiving EGFR therapy for the management of acneiform rash.

To compare the therapeutic efficacy and safety of a single-dose of 0.25 mg or 0.75 mg palonosetron with first generation 5-HT₃ RAs (32 mg ondansetron, 100 mg dolasetron, or 3 mg granisetron) in preventing chemotherapy-induced nausea and vomiting (CINV) with or without IV dexamethasone before initiation of chemotherapy

Databases searched were Medline (1966 to June 2011), EMBASE (1980 to June 2011), American Society of Clinical Oncology, and National Cancer Institute (403 in total).

Search keywords were palonosetron, ondansetron, granisetron, dolasetron, nausea and vomiting.

Studies were included in the review if they were

• Incorporated a parallel-group or crossover design.
• Reported on adult patients receiving moderately or highly emetogenic chemotherapy.
• Provided sufficient data for evaluation of acute antiemetic efficacy.
• Included sufficient details on the adverse effects associated with palonosetron.

Studies were excluded if they had insufficient data on polanestron safety or if the participants were applied more than once in the review.
 

• A total of 16 references were retrieved.
• Homogeneity of effects across studies was assessed by using c2 statistical review.
• Publication bias was evaluated by using a visual inspection of the funnel plot of the fixed or random effect relative risk (RR) of each study on the x-axis and the standard error of the variance of the log RR on the y-axis.
• No evaluation was performed on the trials' quality.

• The final number of studies included was nine. Of these, four used 0.75 mg IV palonosetron.
• The total sample size was 3,463, according to the author (although counting the studies listed in Table 1 yielded a total count of 3,698, and checking each study separately yielded 3,776).
• The sample range of participants across studies was 89–1,114.
• Key sample characteristics were adult patients receiving MEC or higher with various cancer diagnoses.

• Patients were in active treatment.
• This study has application to palliative care and elderly care.

• Complete response (CR) was defined as no emetic episodes and no rescue medication used during the acute, delayed, and overall time intervals after initiation of qualifying chemotherapy. Complete control (CC) was defined as no emetic episodes, no need for rescue medication, and no more than mild nausea for the 0–24 hours, 24–120 hours, and 0–120 hours intervals.
• Compared with the first-generation 5-HT₃ receptor antagonists, the cumulative incidences of emesis were significantly reduced in the patients treated with palonosetron (0.25 mg IV) on the first day (RR = 1.11, 95% confidence interval (CI): 1.05–1.17), from 2 to 5 days (RR = 1.26, 95% CI: 1.16–1.36) and the overall five days (RR = 1.23, 95% CI: 1.13–1.34).
• Regarding drug safety, no significant differences were found between the group treated with palonosetron and the group treated with first-generation 5-HT₃ receptor antagonists.

Results from the analysis suggest that palonosetron is highly effective in preventing nausea and vomiting in the days after administration of moderately or highly emetogenic chemotherapy agents.

To evaluate the therapeutic efficacy and safety of aprepitant for the treatment of chemotherapy-induced nausea and vomiting (CINV) during the first five days following highly or moderately emetogenic chemotherapy

Databases searched were MEDLINE and Embase. Abstracts were searched in the American Society of Clinical Oncology, Cochrane Library, and National Cancer Institute.

Search keywords were aprepitant, MK-869, substance P receptor antagonist, NK-1 receptor antagonist, and chemotherapy-induced nausea and vomiting.

Studies were included in the review if they

• Were randomized controlled trials.
• Compared the efficacy of aprepitant with placebo or no intervention for the prophylaxis of CINV.
• Contained information regarding the complete control of vomiting or nausea during the first 24 hours or the first 24 hours after chemotherapy administration.
• Had at least 80% follow up.

Studies were excluded if they

• Involved patients receiving radiotherapy treatment.
• Only provided pharmacokinetic information.
• Included healthy people or animals.
• Involved patients with depression and other nervous system diseases.
• Had insufficient data on efficacy of aprepitant.
• Had subjects who were applied more than once.
   

• The total number of references initially identified was 327; of these, 29 were retrieved for detailed evaluation.
• The evaluation method was not specified.
• When abstracts and published articles were found on the same population, only the articles were used for analysis.
• When studies used a crossover design, only data during the first cycle was used for analysis.

• The final number of studies included was 15 representing a total of 4,798 patients (2,419 experimental and 2,379 control).
• The sample range across all studies was 45–866.
• Key sample characteristics were not specified.

All patients were in active treatment.

• Incidence of emesis was significantly reduced in the aprepitant group on the first day of chemotherapy (relative response [RR] = 1.13, 95% CI = 1.10–1.16). 
• Incidence of delayed nausea and vomiting from days 2–5 after chemotherapy was also significantly reduced (RR = 1.35, 95% CI = 1.22–1.48). 
• Aprepitant and ondansetron or granisetron demonstrated superior nausea and vomiting control compared to nonaprepitant regimens; however, aprepitant plus palonosetron did not show any superiority. 
• No significant differences were found regarding the occurrence of adverse effects in aprepitant versus control groups.

Aprepitant is effective in the prevention of delayed CINV. Aprepitant improves the antiemetic effect of ondansetron and dexamethasone in patients receiving cisplatin-based chemotherapy.

Aprepitant is effective and safe for the prevention of CINV in the acute and delayed phases of treatment.