Venlafaxine

Venlafaxine

PEP Topic 
Hot Flashes
Description 

Venlafaxine is used to treat depression. Venlafaxine is also sometimes used to treat hot flashes in women who have experienced menopause or who are taking medication to treat breast cancer. Venlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine in the brain. Venlafaxine comes as a tablet or extended-release capsule to take by mouth. Venlafaxine has been studied as an intervention for hot flashes, sleep-wake disturbances, peripheral neuropathy, and fatigue in patients with cancer. 

Likely to Be Effective

Research Evidence Summaries

Biglia, N., Torta, R., Roagna, R., Maggiorotto, F., Cacciari, F., Ponzone, R., … Sismondi, P. (2005). Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flushes in breast cancer survivors. Maturitas, 52, 78–85.

doi:10.1016/j.maturitas.2005.01.001
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Study Purpose:

  • Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flashes in breast cancer survivors
  • Evaluate the efficacy and tolerability of a longer treatment (eight weeks) at a lower dose of venlafaxine (37.5 mg/day)

Sample Characteristics:

  • N = 40
  • Patients attending the outpatient clinic for menopausal symptoms 
  • All witha history of breast cancer without evidence of recurrence and no requirement of fulfilling menopausal status
  • Anti-estrogen therapy was allowed provided that it had been started at least four months before study entry and continued the next three months

Setting:

Outpatient

Study Design:

Open label study

Measurement Instruments/Methods:

Measures included:

  • Hot flash diary and computation of daily hot flash scores
  • Weekly documentation in diariesof side effects experienced  
  • Beck Depression Inventory (BDI) as completed at baseline and at week 8 
  • At weeks 4 and 8,a clinical visit to monitor blood pressure, assess side effects, and hot flash frequency
    • Patient was excluded from study if blood pressure found diastolic above 95 or systolic above 160, or if important side effect occurred

Results:

Thirty patients completed the first 4 weeks of treatment with reduction of hot flash frequency of 39% compared to baseline. After eight weeks of treatment, a further significant reduction in hot flashes by 53% and a hot flash score by 59% was observed. Very few side effects were reported, mainly nausea during first the two weeks and mouth dryness. Only 23 women completed the BDI at week 8 with a reduction of 23% reported. No patient was withdrawn for blood pressure increase or major toxicity.

Conclusions:

Low-dose venlafaxine hydrochloride can be effective in reducing frequency and severity of hot flashes in patients with breast cancer.

Limitations:

  • Not blinded or placebo-controlled  

Boekhout, A. H., Vincent, A. D., Dalesio, O. B., van den Bosch, J., Foekema-Tons, J. H., Adriaansz, S., . . . Schellens, J. H. (2011). Management of hot flashes in patients who have breast cancer with venlafaxine and clonidine: a randomized, double-blind, placebo-controlled trial. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 29(29), 3862-3868.

doi:10.1200/JCO.2010.33.1298
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Study Purpose:

Evaluate the efficacy of venlaxafine and clonidine for hot flashes in patients with breast cancer

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to receive 75 mg venlafaxine,  0.1 mg clonidine, or placebo daily.  Subjects were stratified by age, duration of hot flashes, concurrent endocrine therapy, and previous chemotherapy.   Patients were treated for 12 weeks.  Hot flash scores at week 12 were compared among the three groups.

Sample Characteristics:

N  80 AGE   Median = 49, range 28-71

MALES (%)          FEMALES (%)100%

KEY DISEASE CHARACTERISTICS 31% had age related symptoms, and 99% were post menopausal after breast cancer treatment.  52% received endocrine treatment
 

Setting:

SITE  Multi-site  SETTING TYPE  Outpatient  LOCATION Netherlands

Phase of Care and Clinical Applications:

PHASE OF CARE Late effects and survivorship

Study Design:

 Double blind placebo controlled RCT

Measurement Instruments/Methods:

  • Daily diary of frequency and severity of hot flashes - mild, moderate, severe categorization and calculation of daily hot flash scores
  • Groningen Sleep Quality Index
  • Hospital Anxiety and Depression Score
  • Sexual Activity Questionnaire
     

Results:

Hot flash scores were lower in the clonidine group than the placebo group at week 12 ( p = .03), and lower in the venlaxafine group than placebo, though not statistically significant ( p = .07).  Over the 12-week period, reduction in the venlaxafine group was 41% ( P<.001), 26% in the clonidine group ( p=.045), and 29% in the placebo group (p<.001).  Those on venlaxafine tended to have some loss of appetite ( p = .003) as well as symptoms of nausea.  Sleep and sexual function were not different between the two treatment groups.  At week 12, anxiety and depression scores were higher in the venlafaxine than the clonidine group. (p = .03).  Significantly lower hot flash scores began in the venlafaxine group compared to placebo in weeks 1-4 (p =.01), and in the clonidine group, lower scores began compared to placebo in weeks 5-8 ( p = .04)

Conclusions:

Both venlafaxine and clonidine were slightly more effective than placebo in reducing hot flash symptoms in this group of patients. However, over the 12 weeks, all study groups showed significant reduction in symptoms.

Limitations:

  • Questionable protocol fidelity
  • Other limitations/*explanation  Authors state that the final sample was underpowered.  It is noted that not all patients were compliant with the medications, but is not clearly stated how compliant they were or were not.  No information is given regarding any missing diary data, and reliability of diary and self-report of severity of hot flashes is not clear.  Follow up period was relatively short, so longer term efficacy is not clear.

Nursing Implications:

Findings suggest that venlafaxine and clonidine may be of benefit in reducing hot flash symptoms in women with breast cancer. However, further research is needed for support, because placebo group also showed reduction in hot flashes. Some patients did have side effects from these medications; patients should be monitored for nausea, changes in appetite, anxiety, and depression if these medications are used.

Bordeleau, L., Pritchard, K. I., Loprinzi, C. L., Ennis, M., Jugovic, O., Warr, D., . . . Goodwin, P. J. (2010). Multicenter, randomized, cross-over clinical trial of venlafaxine versus gabapentin for the management of hot flashes in breast cancer survivors. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 28(35), 5147-5152.

doi:10.1200/JCO.2010.29.9230
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Study Purpose:

Evaluate the efficacy of venlafaxine versus gabapentin for hot flashes in breast cancer survivors

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to receive venlafaxine for 4 weeks, then after a 2-4 week washout receive gabapentin for 4 weeks, or to have the medications in the reverse order.    Patients were given venlafaxine 37.5 mg daily for 7 days and then 75 mg daily for 21 days.  Gabapentin was given at 300 mg at bedtime for 3 days, then 2 times daily for 3 days, then 3 times daily for 22 days.  Patients completed a hot flash diary daily.  At baseline, and at the end of each study period, they completed a symptom rating and study questionnaires.

Sample Characteristics:

  • N = 58
  • AGE   Median 55, range 39.6 - 78.7
  • MALES (%)          FEMALES (%)100%
  • KEY DISEASE CHARACTERISTICS
    • All had previous breast cancer and were from 0-20 years since diagnosis. 
    • All had history of bothersome hot flashes. 
    • 79% had hormonal therapy. 
    • 18% had previous treatment for hot flashes.

Setting:

  • SITE  Multi-site 
  • SETTING TYPE  Outpatient 
  • LOCATION Canada

Phase of Care and Clinical Applications:

PHASE OF CARE Late effects and survivorship

Study Design:

Crossover RCT

Measurement Instruments/Methods:

  • SF -36
  • Hot flash severity on VAS
  • Hot flash diary
  • Quality of Life Questionnaire

Results:

Only 38 patients completed all 4 weeks of both drugs, and 12% of those initially entered dropped out.  Of patients who provided data regarding drug preference, the majority preferred venlafaxine (p = .01).   There were no significant differences between treatments on hot flash outcomes, and hot flash scores were reduced from baseline in both groups (p<.001).  Venlaxafine was associated with loss of appetite (p<.01), nausea ( p = .02), constipation (p =.05), and fewer negative mood changes (p = .003).  Gabapentin was associated with more dizziness ( p = .005) and increased appetite (p<.001).  Hot flash scores in all subjects increased during the 2-4 weeks off therapy.  There were no serious adverse effects of the medications.

Conclusions:

  • Both gabapentin and venlaxafine reduced hot flash severity in these patients. 
  • Each medication was associated with (differing) side effects. 
  • More patients preferred venlaxafine.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10%
  • Other limitations/*explanation  It is not clear if patients or observers were blinded to treatment assignments. Subjects not stratified based on age.

Nursing Implications:

The findings suggest that either venlafaxine or gabapentin can be effective in reducing hot flash symptoms in breast cancer survivors.  More patients preferred venlafaxine.  Both drugs have side effects.

Buijs, C., Mom, C.H., Willemse, P.H., Marike Boezen, H., Maurer, J.M., Wymenga, A.N., … Mourits, M.J. (2009). Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients: A double-blind, randomized cross-over study. Breast Cancer Research and Treatment, 115, 573–580.

doi:10.1007/s10549-008-0138-7
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Study Purpose:

Comparison of venlafaxine versus clonidine for the treatment of hot flashes with regard to side effects, efficacy, QOL, and sexual functioning in patients with breast cancer.

Intervention Characteristics/Basic Study Process:

Patients randomly assigned to receive venlafaxine for eight weeks, followed by a wash-out period of two weeks, then eight weeks of clonidine or vice versa

Sample Characteristics:

N = 60 (30 assigned to venlafaxine and 30 to clonidine). Patients with a primary or metastatic breast cancer age 60 years or younger, allowed antitumor hormonal treatment if started one month prior and continued taking throughout treatment period.

Study Design:

Double-blind, randomized, cross-over study.

Measurement Instruments/Methods:

Assessment took place before the start of each drug, then at 2, 8, 12, 18 weeks after treatment began. Six questionnaires were used to compare the drugs' effects on adverse events, efficacy, QOL, and sexual functioning: daily diary on hot flashes, hot flash–related daily interface questionnaire, Medical Outcomes Study Short Form (SF-36), sexual activity questionnaire, and Zung Self-Rating Depression Scale.

Results:

Forty patients completed all treatments, 12 patients only one treatment, 8 patients neither. Dropout rates during venlafaxine were 15 out of 59, versus clonidine, 5 out of 53. Withdrawal rateswere not affected by sequence of treatment. Efficacy: After eight weeks, no difference was seen between the two drugs in reduction of hot flash scores: median 49% for venlafaxine and 55% for clonidine. The drug that the patient received first caused the greatest reduction in hot flash score.

Limitations:

Statistics: based on the testing used to calculate the number of patients needed to detect differences, the sample size was too small to detect difference, which may be the reason no statistical difference was  found between the interventions.

Carpenter, J.S., Storniolo, A.M., Johns, S., Monahan, P.O., Azzouz, F., Elam, J.L., … Shelton, R.C. (2007). Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist, 12, 124–135.

doi:10.1634/theoncologist.12-1-124
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Study Purpose:

Examination of venlafaxine at two doses for efficacy in relation to physiologic and self-reported hot flashes and other outcomes

Intervention Characteristics/Basic Study Process:

  • Study duration: 14 weeks 
  • Low-dose arm:  6 weeks at 37.5 mgof venlafaxine daily 
  • High-dose arm: consisted of 1 week of 37.5 mg of venlafaxine daily, 4 weeks of 75 mg daily, and one week of 37.5 mg daily
  • Weeks 1 and 2 provided baseline data 
  • Weeks 3–14 included 6 weeks of treatment and 6 weeks of placebo

Sample Characteristics:

  • Breast cancer survivors  recruited between 2000–2004 with follow up continuing through 2005 
  • Must have been postmenopausal or using an approved method of birth control
  • Low-dose study (n = 64, cancer clinics in the Southeast)
  • High-dose study (n = 20, cancer clinics in the Midwest)

Setting:

Outpatient cancer clinics

Study Design:

Randomized, double-blind, placebo-controlled crossover trial

Measurement Instruments/Methods:

A psychologist verified absence of depressive symptoms using two measures: Structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders and the 17-item Hamilton rating scale depression. Adherence to the treatment was assessed using capsule counts and weekly written verification. Physiologic hot flash frequency was evaluated using weekly 24-hour ambulatory sterna skin conductance monitoring and self-reported hot flash diaries. Weekly blood pressure monitoring and other tools were used for side effect monitoring.

Results:

Venlafaxine resulted in modest hot flash reduction, but only hot flash interference improved differentially at the higher dose. Timing of effects varied by dose. Only women who experienced a greater than 50% decrease in physiologic hot flashes also experienced a significant improvement in fatigue, sleep quality, and QOL. Although side effects were mild, most patients discontinued venlafaxine long term.

Limitations:

A placebo effect occurred for self-report of hot flashes but not for physiologic hot flashes in the high- and low-dose arms.

Main study limitations:

  • Racially and ethnically homogeneous samples
  • Limited treatment time
  • Small sample size
  • Lack of pharmacogenetic data. Also limitations regarding
  • Assessing hot flashes with self-reporting is subject to placebo effects

Irani, J., Salomon, L., Oba, R., Bouchard, P., & Mottet, N. (2010). Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncology, 11(2), 147-154.

doi:10.1016/S1470-2045(09)70338-9
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Study Purpose:

Compare the efficacy of 3 drugs in preventing hot flashes in men receiving  hormone treatment for prostate cancer

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to receive wither venlafaxine delayed release 75 mg/day, medroxyprogesterone 20 mg/day or cyproterone acetate 100 mg/day in addition to leuprorelin injections.  Patients were followed up at 4, 8 and 12 weeks.  Patients completed daily hot flush diaries and categorised hot flush severity

Sample Characteristics:

  • N  309 AGE   Not reported
  • MALES (%) 100%         FEMALES (%)
  • KEY DISEASE CHARACTERISTICS All had prostate cancer treated with hormonal therapy for at least 6 months.  All had experienced 14 or more hot flushes in the week before study entry

Study Design:

 Double blind randomized controlled trial

Measurement Instruments/Methods:

  • Daily hot flush diary
  • European Organization for Research and Treatment of Cancer Quality of life questionnaire ( EORTC-QLC 30)
     

Results:

Patients in the medroxyprogesterone group had higher hot flash scores at baseline.  The reduction in daily hot flush scores at 4 weeks was significantly lower for all 3 groups (p<.0001).  Improvements were significantly lower in the venlafaxine group than either of the other 2 groups ( p = .0006), and patients ratings of efficacy of treatment showed that significantly fewer patients in the venlafaxine group rated the treatment as good ( p<.0001) compared to the other 2 groups. Adverse events related to the study drugs were not significantly different between groups, though cyproterone led to a non significantly higher number of vascular adverse events.  The most frequent adverse events were gastrointestinal, including pain, constipation, diarrhea and nausea.  GI events were more frequent with venlafaxine.

Conclusions:

Men with significant hot flushes during androgen suppression for prostate cancer appeared to respond better to cyproterone acetate and medroxyprogesterone acetate than to venlafaxine

Limitations:

  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Other limitations/*explanation  No control or placebo group precluded observation of placebo effect.  The sample was limited to patients who sought treatment for hot flashes.  This was a short follow up period - longer term efficacy is not known. Effects of hormonal treatment for hot flashes on prostate cancer are not known.

Nursing Implications:

It appears that hormonal treatment is more effective in than venlafaxine for management of hot flashes in patients who are receiving androgen suppression for prostate cancer.  Results also showed that many men did not seek treatment for this problem, suggesting that nurses may need to directly assess these patients for problems with hot flash symptoms.  Effects of steroidal anti androgens on prostate cancer are not clear, and patients receiving both androgen suppression and cyproterone or medroxyprogesterone could have increases in prostate specific antigen concentrations.

Loibl, S., Schwedler, K., von Minckwitz, G., Strohmeier, R., Mehta, K.M., & Kaufmann, M. (2007). Venlafaxine is superior to clonidine as treatment of hot flashes in breast cancer patients—A double-blind, randomized study. Annals of Oncology, 18, 689–693.

doi:10.1093/annonc/mdl478
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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

Sample Characteristics:

  • 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

Setting:

University hospital setting

Study Design:

Double-blind, randomized study

Measurement Instruments/Methods:

  • 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

Results:

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.

Limitations:

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

Loprinzi, C.L., Kugler, J.W., Sloan, J.A., Mailliard, J.A., LaVasseur, B.I., Barton, D.L., … Christensen, B.J. (2000). Venlafaxine in management of hot flashes in survivors of breast cancer: A randomised controlled trial. Lancet, 356, 2059–2063.

doi:10.1016/S0140-6736(00)03403-6
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Study Purpose:

Assess more definitively than previous studies the efficacy and toxicity of various doses of venlafaxine for treatment of hot flashes in the breast cancer survivor

Intervention Characteristics/Basic Study Process:

Participants were assigned to placebo (n = 56), or venlafaxine 37.5 mg daily (n = 56), 75 mg daily (n = 55), or 150 mg daily (n = 54).

Sample Characteristics:

Patients eligible for this trial were 221 women who had a history of breast cancer or who were concerned about taking estrogen therapy for fear of developing breast cancer.

  • Inclusion criteria:
    • Troublesome hot flashes, occurring at least 14 times per week; hot flashes severe enough for the patient to desire therapeutic intervention, and present for at least one month prior to study entry, older than 18 years; life expectancy at least 6 months; and ECOG performance status of 0–1.
    • Anti-estrogens and aromatase inhibitors were allowed if they had been started four weeks prior to study entry and scheduled to continue for the next five weeks.
  • Exclusion criteria:
    • Concomitant therapies not allowed: antineoplastic chemotherapy, androgens, estrogens, progestins, antidepressants, clonidine, and combined ergotamine, alkaloids of belladonna, and phenobarbital.   
    • Use of venlafaxine in the past, any antidepressant treatment within the preceding two years, pregnancy, breastfeeding, use of other medications to treat hot flashes within the past two weeks, uncontrolled hypertension.

Study Design:

Double-blind, placebo-controlled, randomized trial

Measurement Instruments/Methods:

  • The primary endpoint:  bivariate construct of average daily hot flash activity: the number of hot flashes and a score combining the number and severity of hot flashes
  • Hot flash diaries
  • Participants stratified by age (younger than 50 versus older than 50), current tamoxifen use, duration of hot flashes (less than 9 versus more than 9 months) and frequency of hot flashes/day.

It was calculated that a sample size of 50 patients per group would provide 80% power to detect differences in average hot-flash activity of standard deviation (SD) 0–6 (1–2 hot flashes per day, a score of 3 units, or a 21% fall from baseline) with a type 1 error rate of 5%.

Results:

Of the 229 patients who joined the study, 191 had data evaluable over the whole study period (50 from the placebo group, 49 from the venlafaxine 37.5 mg group, 43 from the venlafaxine 75 mg group, and 49 from the venlafaxine 150 mg group). After week 4 of treatment, median hot flash scores were reduced from baseline by 27%, 37%, 61%, and 61%, respectively, in the four groups. Frequencies of some side effects (mouth dryness, decreased appetite, nausea, and constipation) were significantly higher in the venlafaxine 75 mg and 150 mg groups than in the placebo group.

Conclusions:

The trial suggests that venlafaxine can alleviate hot flashes and that the most appropriate dose for this indication is 75 mg.

Limitations:

Missing data were handled in several ways as a sensitivity analysis of the robustness of the results in relation to the missing data. Less than 10% of possible data were missing, and the results were consistent across a series of analyses by various imputation methods.

Nursing Implications:

The study makes mention that venlafaxine may also be effective against hot flashes in men who have undergone androgen deprivation therapy for prostate cancer.

Vitolins, M.Z., Griffin, L., Tomlinson, W.V., Vuky, J., Adams, P.T., Moose, D., . . . Shaw, E.G. (2013). Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. Journal of Clinical Oncology, 31, 4092–4098.  

doi: 10.1200/JCO.2012.48.1432
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Study Purpose:

To determine the effectiveness of venlafaxine, soy, and a combination of venlafaxine and soy on hot flashes in men with prostate cancer

Intervention Characteristics/Basic Study Process:

Participants randomly were assigned to one of four groups: daily placebo pill in the morning plus daily milk powder (20 g per day); daily venlafaxine (75 mg) in the morning plus daily milk powder (20 g per day); daily placebo pill in the morning plus daily soy powder (20 g with 160 mg isoflavones); or daily venlafaxine (75 mg) in the morning plus daily soy powder (20 g with 160 mg isoflavones). Venlafaxine was provided in extended-release capsules. Prior to enrollment, participants completed a seven-day prescreening period. The intervention was administered for 12 weeks. Patients kept a daily log of medications and were contacted via phone at week 2, 4, 8, and 12 to assess toxicities and complete study measures. Patients on venlafaxine were titrated off medication after the end of the study.

Sample Characteristics:

  • N = 119
  • MEAN AGE = 68.5 years
  • AGE RANGE = 46–91 years
  • MALES: 100%
  • KEY DISEASE CHARACTERISTICS: Prostate cancer

Setting:

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: United States

Phase of Care and Clinical Applications:

PHASE OF CARE: Late effects and survivorship

Study Design:

  • RCT, double-blind, placebo-controlled, 2 x 2 factorial design

Measurement Instruments/Methods:

  • Daily count of hot flashes
  • Hot Flash Symptom Severity Score (HFSSS)
  • Functional Assessment of Cancer Therapy-Prostate (FACT-P)
  • Body mass index (BMI)

Results:

There was no significant difference in sample characteristics between the four groups including severity of disease, BMI, performance status, and type of treatment. Vasomotor symptoms decreased in all arms (p < 0.001). No differences existed between treatment arms at baseline and 4, 8, or 12 weeks. The severity of hot flashes decreased in all arms (p < 0.001). All four arms showed a decrease in the HFSSS (p < 0.001). Toxicities did not differ between groups and were mild. The study was ended by the Data Safety Monitoring Board due to a lack of effect. The placebo group had the largest decrease in HFSSS scores (55%).

Conclusions:

In men with prostate cancer, venlafaxine, soy, and a combination of the two were no more effective than a placebo at decreasing the number and severity of hot flashes.

Nursing Implications:

Venlafaxine, soy, and a combination of both are not effective at treating hot flashes in men with prostate cancer.


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