Compare venlafaxine to another nonhormonal agent in the treatment of hot flashes in patients with breast cancer

Patients were randomized to receive 0.075 mg clonidine twice daily or venlafaxine 37.5 mg twice daily for four weeks then crossover.

• Women with breast cancer experiencing hot flashes at least 14 times per week (N = 80). 64 patients completed study 
• Majority older than age 50 years 
• 40 randomized to each group.
  • 33 received clonidine, 31 received venlafaxine 
  • 9 stopped early because of side-effects
  • 7 withdrew
• Inclusion:
  • Adult women with primary breast cancer experiencing hot flashes at least 14 times per week or must have been seeking help for hot flashes. Hot flashes present at least four weeks before study entry.
  • Predefined menopausal status as not required.
  • Tamoxifen, gonadotropin-releasing agonists, and aldose reductase inhibitors  allowed as long as the patients had been on such therapy for at least a month and were planning to continue therapy during study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Exclusion:
  • Previous treatment with venlafaxine and clonidine as well as estrogens, progestagens, or androgens for hot flashes
  • Current treatment with hypertensive or antidepressant agents, other nonhormonal agents for hot flashes such as black cohosh, isoflavones, and vitamin E 
  • Patients with hypertension or hypotension, peripheral or cardiovascular diseases, or symptomatic cardiac diseases

University hospital setting

Double-blind, randomized study

• Self-reported one-week hot flash and other symptom questionnaire assessed one week before start of treatment and end of treatment.
  • Hot flashes: frequency and severity
  • Symptoms assessed: Loss of appetite, mouth dryness, nausea, tiredness, constipation, restless sleep, nervousness, sweating, dizziness, mood disorder, diarrhea, sleeplessness

At end of week 4, the median hot flash frequency dropped by 7.6 hot flashes per day for patients receiving venlafaxine and 4.85 hot flashes for those receiving clonidine (p = .025). Nausea was significantly greater with venlafaxine compared with clonidine. Mouth dryness, constipation, and restless sleep were reported more with clonidine but the difference was not statistically significant.

• Small sample size with less than 100 participants 
• Short follow-up period

To examine the usefulness of transcutaneous electrical nerve stimulation (TENS) for cancer-related pain and functionality

Records of patients who received TENS were reviewed for data collection. High-frequency TENS was trialed. Patients who reported subjective pain relief were provided with a TENS unit and instructed to use it four to six times daily for 30–60 minutes. Prior to the trial, pain was assessed. Pain was reassessed between one and two months.

• N = 55
• AGE RANGE = 10–89 years
• MALES: 22%, FEMALES: 78%
• KEY DISEASE CHARACTERISTICS: Varied tumor types

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: New York, NY

• APPLICATIONS: Palliative care

Retrospective, descriptive study

• Visual Analogue Scale (VAS)
• Numeric Rating Scale (NRS)
• McGill Pain Questionnaire Short Form (MPQ-SF)

Overall, 69.7% of patients who trialed TENS reported benefits. Among those who responded to TENS (40 patients), there was an average VAS score decrease of 9.8 mm (p < 0.001).

TENS may be helpful for pain management in patients with cancer. The results from this study were inconclusive.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Other limitations/explanation: No information about whether analgesics were used or changed over time was provided. The results reporting was confusing, and the sample sizes reported in various places differed.

This study's findings regarding the efficacy of TENS for cancer-related pain treatment were not conclusive. Well-designed research evaluating its efficacy is needed so that options for improved pain management can be identified. Modalities such as TENS may be helpful adjuncts for patients who experience limited effectiveness with standard analgesics. However, good supporting evidence is needed.

To assess data to determine the effect of abiraterone acetate on pain and skeletal events in patients with castration-resistant prostate cancer

Patients were randomized to receive either 1 g abiraterone acetate or placebo orally once a day, along with 5 mg prednisone twice daily for 28-day cycles. Concomitant bisphosphonates were allowed during the study, if patients were already taking them or if a skeletal event indicated their use. Assessments occurred at baseline, on day 15, and on day 1 of the first 28-day cycle and during each subsequent 28-day cycle until the end of the study or treatment discontinuation.

• The sample was composed of 1,195 patients.
• Mean patient age was 69 years. Age range was 39–95 years.
• All the patients in the sample were male.
• All patients had castration-resistant prostate cancer. Overall, 43% of patients were using bisphosphonates and 89.4% had bone metastases.

• Multisite
• Outpatient
• Multiple countries

• Phases of care: late effects and survivorship
• Clinical application: palliative care

Randomized double-blind, placebo-controlled trial

Brief Pain Inventory

• Compared to patients taking placebo, a significantly larger proportion of patients receiving abiraterone acetate (p < 0.005) reported palliation of pain and pain interference.
• Median duration of pain palliation, 4.2 months, was longer in the abiraterone group (p = 0.0056).
• The proportion of patients to experience skeletal events was similar in both groups.
• Time to skeletal events was longer for patients taking abiraterone acetate (p = 0.0001).
• Both groups showed decline in pain intensity and interference over time.
• Median follow-up period for varied outcomes was 1–9.3 months. Follow-up survival curve analysis outcomes were better for those receiving abiraterone (p = 0.05).

Compared to placebo, abiraterone acetate and prednisone were associated with favorable effects on pain and a longer time to skeletal events in patients with metastatic castration-resistant prostate cancer.

• The findings of this analysis are not generalizable.
• The study was not stratified by use or nonuse of bisphosphonates.
• Authors provided very limited information and analysis regarding analgesic use and changes in analgesic use over the course of the study.

Findings show that prednisone and abiraterone acetate appeared to improve pain control in patients with castration-resistant prostate cancer. Chronic bone-related pain can be a severe problem for late-stage patients with prostate cancer. For these patients, abiraterone acetate and prednisone can be helpful in reducing pain and delaying skeletal events.

To evaluate the effectiveness of thee Tracheostomy Care Anxiety Relief through Education and Support (T-CARES) educational program for decreasing caregiver anxiety and increasing caregiver competence with tracheostomy suctioning

T-CARES is a one-hour course for caregivers about caring for a tracheostomy. The course is offered once a week in the hospital unit in a group setting. It involves an 18-minute video, group discussion, hands-on practice, and a return demonstration of tracheostomy care. The course covers the following topics: the introduction to airway anatomy, components of a tracheostomy tube, tracheostomy suctioning, stoma care, changing the ties securing the tracheostomy, cleaning the inner cannula, preparing for the unexpected, reinsertion of the tracheostomy tube after accidental decannulation, how to handle a mucous plug, when to call the doctor, and self-care. Evaluations were done at baseline and postintervention.

• N = 11  
• MEDIAN AGE = 50. 8 years (range = 31–69 years)
• MALES: 64%, FEMALES: 36%
• KEY DISEASE CHARACTERISTICS: Caregivers of patients with head and neck cancer with new tracheostomies
• OTHER KEY SAMPLE CHARACTERISTICS: 90% Caucasian; 81% had a high school education or above; and 90% had no prior tracheostomy experience

• SITE: Single site    
• SETTING TYPE: Inpatient  
• LOCATION: Central Florida

• PHASE OF CARE: Multiple phases of care

Nonexperimental, self-selected to receive the intervention pre- and post-test pilot study

• State-Trait Anxiety Inventory (STAI)
• Suctioning competency checklist
• Course evaluation

Mean STAI scores dropped from 50.5 to 34.3 after the intervention (p = 0.008). All participants were able to perform nine of the 14 skills needed for tracheostomy suctioning. Course evaluations were positive.

T-CARES is an effective intervention for reducing caregiver anxiety and increasing caregiver competency of tracheostomy care.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding) 
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Questionable protocol fidelity
• Other limitations/explanation: No mention of how these registered nurses and trainers were calibrated as trainers although the protocol was standardized in its content and delivery; no mention of how the registered nurses and trainers who helped caregivers learn were trained in a standardized way themselves

Nurse-developed caregiver educational programs may be useful in decreasing anxiety and increasing competency for the development of new caregiver skills required for quality patient care. Additional research in this area is indicated.

To compare and evaluate the efficacy, safety, acceptance, and one-year outcome of two laxatives, polyethylene glycol (PEG) without electrolytes and milk of magnesia (MOM).

Patients were randomly assigned to intervention with PEG 3350 without electrolytes (Miralax^®) or MOM by drawing a sealed envelope. Patients initially received 0.7 g/kg of PEG or 2 ml/kg of MOM daily.

• A total of 117 children were asked to participate; 79 were enrolled and randomized.
• The PEG group comprised 39 patients (31 boys and 8 girls), whereas the MOM group comprised 40 patients (34 boys and 6 girls).
• Patients were included in the study if they were new referrals (more than one per week), were aged four years or older, and had presence of functional constipation with fecal incontinence.
• Patients were excluded if they had stool toileting refusal, fecal incontinence without constipation, previously refused one of the study medications, Hirschsprung disease, previous surgery involving the colon, chronic intestinal pseudo-obstruction, or come for a second opinion.

Children’s Hospital of Iowa

Randomized controlled trial

• Improvement was defined as three or more bowel movements (BMs) per week and two or fewer episodes of fecal incontinence per month with no abdominal pain, with or without laxative.
• Recovery was defined as three or more BMs per week and two or fewer episodes of fecal incontinence per month with no abdominal pain, without laxative treament for at least one month.
• Children who received additional senna were counted as not improved or recovered.

• Baseline characteristics were not significant (p > 0.07).
• Compliance rates were significant at 95% for the PEG group and 65% for the MOM group.
• After 12 months, 62% of the PEG group and 43% of the MOM group exhibited improvement and 33% of the PEG group and 23% of the MOM group recovered (not significant).

PEG and MOM are effective and safe in long-term treatment, with PEG having better acceptance.

• The study had a high drop-out rate (loss to follow-up).
• The study did not measure biochemical profiles for all children.

Placebo versus two treatment arms of recombinant coagulation factor VIIa: 20 mcg/kg and 80 mcg/kg

• N = 204
• OTHER KEY SAMPLE CHARACTERISTICS: Noncirrhotic adults undergoing partial hepatectomy for cancer and/or benign tumors

• Placebo-controlled RCT

• Designed for 50% relative reduction
• Outcome measures included erythrocyte transfusion during or 48 hours after surgery
• Amount of erythrocytes transfused
• Change in hematocrit
• Requirement of fresh frozen plasma
• Surgery time
   

Perioperative transfusion difference approached significance (P = 0.09). Mean requirements decreased with rFVIIa (P = 0.78). Blood loss during surgery decreased (P = 0.07).





 

• 80% power
• Significance level 5%
• Exceeded 180 sample size
• No statistically significant results
• Larger trial needed for better evaluation

A larger trial is needed for better evaluation.

Patients were given a 5-mg pilocarpine tablet or placebo starting the day before the conditioning regimen, every 4 hours, for a total of 4 tablets per day. Patients continued taking tablets until absolute neutrophil count (ANC) was greater than 500 for 48 hours, discharge from hospital, or mucosal recovery.

• The study reported on 36 patients with 20 receiving pilocarpine and 16 receiving placebo.
• Patients were undergoing autologous stem cell transplant (SCT) with multiple (not all hemotologic) malignancies.

This was a prospective, double-blind, randomized, placebo-controlled trial. Patients were stratified by diagnosis and randomized by a computer-generated numbering scheme.

• The World Health Organization (WHO) mucositis scale and CMC outcome measures toxicity criteria were used.
• Numerous outcomes were measured.

• No statistically significant differences were found in the incidence, severity, or duration of mucositis.
• Pain at rest and with swallowing and the use of systemic narcotics were not significantly different.
   

Despite prior small trials that showed a benefit, this study clearly did not.  The intervention was not effective.

A standardized scoring system is needed.

1. Six sessions (50 minutes) of cognitive rehabilitation focused on purpose of a memory notebook and a calendar with a specific format as an external aid to compensate for cognitive symptoms.   
2. Six sessions of problem-solving therapy over two weeks focused on the ABC method of constructive thinking and problem solving.

• Enrolled: 7 control and 12 Tx
• Completed CRP: 6 control and 8 Tx
• Three-month F/U: 5 control and 8 Tx

*Withdrawals were due to tumor progression; new onset seizures; time commitment; caregiver issues; and fatigue.

• Tx group: 7 men, 5 women
• Controls: 4 men, 3 women

1. Newly diagnosed PBT prior to or during XRT
2. 18 years of age or older
3. Mild or moderate cognitive impairment based on neuropsych testing from the clinical assessment of the neuropsychologist
4. Prognosis of at least six months
5. Ability to attend sessions at the institution for two weeks
6. Designated caregiver must attend all sessions.

• SITE: Single site  
• LOCATION: Mayo Clinic

Randomized controlled trial; longitudinal

1. Baseline cognitive function (R-BANS) showed that control group scored lower than intervention group for memory.
2. Baseline cognitive function was used only as a comparison for those who completed all time points in the study as compared to those who did not.

1. Implementation of compensation strategies was used by 88% of subjects several times/week to several times/day after intervention completion; reduced to 50% at three-month follow-up (88% used at least once/week at three months).
2. 88% found intervention somewhat helpful to very helpful; 50% found cognitive intervention helpful, whereas 25% found problem-solving most helpful and 25% found both equally helpful; 88% would recommend to another PBT patient; caregivers had similar feedback about the program.

1. Study demonstrated feasibility of patient participation and satisfaction with cognitive rehabilitation and problem-solving therapies; despite low accrual, most completed program.
2. Most intervention subjects reported continued use of compensation strategies to some degree at three months.
3. This sample reported relative stable measures for QOL.
4. Recommend targeting patients reporting poor QOL, poor day-to-day functional performance, or emotional distress for the intervention.
5. Recommend larger stratified study to control for varying tumor characteristics and treatment differences (chemotherapy).

1. Small sample size with low accrual over two years. This altered randomization with the last three dyads placed into the intervention group.
2. Low accrual may have occurred due to the definition used for cognitive impairment as 38% of potential subjects referred for enrollment were not eligible.
3. Intervention occurred concurrently during radiation therapy treatments for two consecutive weeks, which most likely contributed to low accrual and can increase burden (especially for some who may have continued to work).
4. Cognitive measure (R-BANS) was utilized for a comprehensive assessment of cognitive function only at baseline. Long-term follow-up was not performed as originally planned with study design.
5. No educational level was reported for subjects.

To determine if a focused narrative-interview intervention can alleviate symptoms of suffering, anxiety, and depression in patients with advanced cancer

Patients in a hospice day unit were randomized to one of two groups. In one, patients received the study intervention; in the other, usual care. The intervention was a single focused narrative interview in which a patient was encouraged to discuss his or her perspectives; sense of meaning; sense of suffering; and psychological, physical, and spiritual well-being. The emphasis was on enabling each patient to tell his or her story. Study assessments were done at baseline and at two, four, and eight weeks after the intervention.

• The sample was composed of 100 participants.
• Mean patient age was 66 years. The age range was 31–89 years.
• Of all participants, 32% were male and 68% were female.
• All patients had advanced disease, and the sample included various tumor types. Of types of cancer represented in the sample, breast, lung, and colon cancer were the most common.
• Of all participants, 55% were married or cohabiting; 33.3% had been diagnosed with cancer within the last 12 months; and approximately 33.3% had, before cancer diagnosis, disorders related to depression or stress.

• Single site
• Outpatient
• United Kingdom

• Phase of care: end-of-life care
• Clinical applications: eldercare, palliative care

 Randomized controlled trial

• Brief Edinburgh Depression Scale (BEDS)
• Edmonton Symptom Assessment Scale (ESAS)
   

Baseline scores indicated, on average, probable depression. At four weeks investigators noted a slight, but nonsignificant improvement in the depression score. Authors noted no other changes or differences between groups.

As result of narrative interview intervention in a hospice day program, findings did not show any substantial improvement in measures of depression or other symptoms.

• The study had a small sample size, with fewer than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Authors did not describe usual care. Although the authors noted no significant differences as a result of the intervention, authors concluded that the intervention was effective.

Findings do not suggest that narrative interview, used as an intervention for depression and other symptoms, had any effect in this study.

To observe the longitudinal effects of antidepressant medication in a cohort of patients with advanced cancer

Of the 628 patients with advanced cancer in the study, 25% were receiving antidepressants for a median of 9.5 weeks. Patients were followed for six months or until death. Consecutive patients in the daycare unit were eligible for inclusion. Patients completed study assessments at baseline and at eight, 16, and 24 weeks. A patient self-report was used to identify patients taking antidepressants.

• N = 628  
• AVERAGE AGE = 66
• MALES: 33%, FEMALES: 67%
• KEY DISEASE CHARACTERISTICS: Advanced cancer; any tumor type
• OTHER KEY SAMPLE CHARACTERISTICS: Enrolled in hospice

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Hospice day units, northwest England

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Elder care and palliative care 

Observational

• Patient Health Questionnaire (PHQ-9) 
• Edinburgh Depression Scale (EDS)

Patients who stated that they took antidepressants had significantly higher depression scores on both measures. A subgroup analysis was completed for those with the highest PHQ-9 scores, assuming that effects might be seen in those with greater depression levels. However, there were no differences in results between those taking and not taking antidepressants.

The observational findings of this study suggest that antidepressant medication had little impact in reducing depression scores for patients attending Hospice daycare service.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: Hospice day treatment; other treatments in use as well as antidepressants; difficult to determine what was the cause of change; patient self-report only used to identify those taking antidepressants and was not corroborated with medical records or any other source information

This observational study did not show that antidepressants reduced depression among patients receiving Hospice care. However, there were several study design and measurement limitations. The role and effectiveness of antidepressants may vary among patients at different phases in the trajectory of cancer.