Pilot evaluation of venlafaxine hydrochloride for the therapy of hot flashes in cancer survivors.

PURPOSE Hot flashes can be a prominent clinical problem for breast cancer survivors and men who undergo androgen-deprivation therapy. Anecdotal information suggested a low dose of a relatively new antidepressant, venlafaxine, could abrogate this clinical problem. MATERIALS AND METHODS This study included 28 consecutive assessable patients entered onto a phase II clinical trial. Hot flash data were collected by daily diary questionnaires during a 1-week baseline period and then for 4 weeks, during which time patients received venlafaxine 12.5 mg orally twice daily. RESULTS Fifty-eight percent of patients who completed the study had a greater than 50% reduction in hot flash scores (frequency times severity) during the fourth treatment week as compared with the baseline week. Median weekly hot flash scores were reduced by 55% from baseline during the fourth week of venlafaxine therapy. Therapy was generally well tolerated and appeared to alleviate fatigue, sweating, and trouble sleeping. CONCLUSION Venlafoxine appears to represent an efficacious new method to alleviate hot flashes. Further evaluation of this compound for alleviating hot flashes is indicated.

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Prospective evaluation of vitamin E for hot flashes in breast cancer survivors.

Journal of Clinical Oncology ◽

10.1200/jco.1998.16.2.495 ◽

1998 ◽

Vol 16 (2) ◽

pp. 495-500 ◽

Cited By ~ 283

Author(s):

D L Barton ◽

C L Loprinzi ◽

S K Quella ◽

J A Sloan ◽

M H Veeder ◽

...

Keyword(s):

Breast Cancer ◽

Vitamin E ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Hot Flashes ◽

Clinical Problem ◽

Baseline Period ◽

Similar Reduction ◽

Hot Flash ◽

Crossover Analysis

PURPOSE Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter. METHODS We developed and conducted a placebo-controlled, randomized, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods. RESULTS The 120 patients evaluated for toxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively). CONCLUSION Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal.

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Evaluation of Soy Phytoestrogens for the Treatment of Hot Flashes in Breast Cancer Survivors: A North Central Cancer Treatment Group Trial

Journal of Clinical Oncology ◽

10.1200/jco.2000.18.5.1068 ◽

2000 ◽

Vol 18 (5) ◽

pp. 1068-1068 ◽

Cited By ~ 259

Author(s):

Susan K. Quella ◽

Charles L. Loprinzi ◽

Debra L. Barton ◽

James A. Knost ◽

Jeff A. Sloan ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Hot Flashes ◽

Clinical Problem ◽

Baseline Period ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Hormonal Therapies ◽

Blind Manner

PURPOSE: Hot flashes represent a significant clinical problem for some breast cancer survivors. Safe, effective treatment is needed for this prominent clinical problem. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. Based on anecdotal information, we hypothesized that soy-derived phytoestrogens, weak estrogen-like substances in the soybean that demonstrate estrogen agonist and/or antagonist effects when they bind to estrogen receptors, could alleviate hot flashes. This current trial was designed to investigate this hypothesis. PATIENTS AND METHODS: This double-blind clinical trial involved breast cancer survivors with substantial hot flashes. After randomization, patients underwent a 1-week baseline period with no therapy. This was followed by 4 weeks of either soy tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. Patients completed a daily questionnaire documenting hot flash frequency, intensity, and perceived side effects. RESULTS: Of the 177 women who were randomized and started the study substance, 155 (88%) provided useable data over the first 5 weeks; 149 provided usable data over the entire 9 weeks. There was no suggestion that the soy product was more effective in reducing hot flashes than the placebo. At study completion, patients preferred the soy product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed. CONCLUSION: The soy product did not alleviate hot flashes in breast cancer survivors.

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Multicenter, Randomized, Cross-Over Clinical Trial of Venlafaxine Versus Gabapentin for the Management of Hot Flashes in Breast Cancer Survivors

Journal of Clinical Oncology ◽

10.1200/jco.2010.29.9230 ◽

2010 ◽

Vol 28 (35) ◽

pp. 5147-5152 ◽

Cited By ~ 64

Author(s):

Louise Bordeleau ◽

Kathleen I. Pritchard ◽

Charles L. Loprinzi ◽

Marguerite Ennis ◽

Olivera Jugovic ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Patient Preference ◽

Breast Cancer Survivors ◽

Negative Mood ◽

Hot Flashes ◽

Baseline Period ◽

Open Label ◽

Group Sequential ◽

Hot Flash

Purpose Nonhormonal pharmacologic interventions are recommended for the treatment of hot flashes in breast cancer survivors. Antidepressants and gabapentin have been shown to be both effective and well tolerated; however, it is not clear which is preferred. Patients and Methods This was a group-sequential, open-label, randomized, cross-over trial of 4 weeks of venlafaxine (37.5 mg daily for 7 days followed by 75 mg daily for 21 days) versus gabapentin (300 mg once per day for 3 days, then 300 mg twice per day for 3 days, then 300 mg three times per day for 22 days), with patient preference as the primary outcome. Postmenopausal women with at least 14 bothersome hot flashes per week for the prior month were eligible. A 2-week baseline period and a 2-week tapering/washout time was used before the first and second treatment periods, respectively. Diaries were used to measure hot flashes and potential toxicities throughout the study. Participants completed a preference questionnaire at the end of the study. A predefined Pocock stopping rule was applied. Patient preference and hot flash and toxicity outcomes were compared between treatments. Results Sixty-six patients were randomly assigned, 56 of whom provided a preference (eight dropped out and two had no preference); 18 (32%) preferred gabapentin and 38 (68%) preferred venlafaxine (P = .01). Both agents reduced hot flash scores to a similar extent (66% reduction). Venlafaxine was associated with increased nausea, appetite loss, constipation, and reduced negative mood changes compared with gabapentin, whereas gabapentin was associated with increased dizziness and appetite compared with venlafaxine (all P < .05). Conclusion Breast cancer survivors prefer venlafaxine over gabapentin for treating hot flashes.

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Cooling off hot flashes: uncoupling of the circadian pattern of core body temperature and hot flash frequency in breast cancer survivors

Menopause The Journal of The North American Menopause Society ◽

10.1097/01.gme.0000132624.84597.9f ◽

2004 ◽

Vol 11 (4) ◽

pp. 369-371 ◽

Cited By ~ 1

Author(s):

Karen Elkind-Hirsch

Keyword(s):

Breast Cancer ◽

Body Temperature ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Core Body Temperature ◽

Hot Flashes ◽

Circadian Pattern ◽

Hot Flash ◽

Core Body

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Randomized Trial of a Hypnosis Intervention for Treatment of Hot Flashes Among Breast Cancer Survivors

Journal of Clinical Oncology ◽

10.1200/jco.2008.16.6389 ◽

2008 ◽

Vol 26 (31) ◽

pp. 5022-5026 ◽

Cited By ~ 104

Author(s):

Gary Elkins ◽

Joel Marcus ◽

Vered Stearns ◽

Michelle Perfect ◽

M. Hasan Rajab ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Hot Flashes ◽

Female Breast Cancer ◽

Daily Activities ◽

Secondary Outcome ◽

Control Group ◽

Hot Flash ◽

History Of

Purpose Hot flashes are a significant problem for many breast cancer survivors. Hot flashes can cause discomfort, disrupted sleep, anxiety, and decreased quality of life. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. On the basis of previous case studies, this study was developed to evaluate the effect of a hypnosis intervention for hot flashes. Patients and Methods Sixty female breast cancer survivors with hot flashes were randomly assigned to receive hypnosis intervention (five weekly sessions) or no treatment. Eligible patients had to have a history of primary breast cancer without evidence of detectable disease and 14 or more weekly hot flashes for at least 1 month. The major outcome measure was a bivariate construct that represented hot flash frequency and hot flash score, which was analyzed by a classic sums and differences comparison. Secondary outcome measures were self-reports of interference of hot flashes on daily activities. Results Fifty-one randomly assigned women completed the study. By the end of the treatment period, hot flash scores (frequency × average severity) decreased 68% from baseline to end point in the hypnosis arm (P < .001). Significant improvements in self-reported anxiety, depression, interference of hot flashes on daily activities, and sleep were observed for patients who received the hypnosis intervention (P < .005) in comparison to the no treatment control group. Conclusion Hypnosis appears to reduce perceived hot flashes in breast cancer survivors and may have additional benefits such as reduced anxiety and depression, and improved sleep.

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Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flushes in breast cancer survivors

Maturitas ◽

10.1016/j.maturitas.2005.01.001 ◽

2005 ◽

Vol 52 (1) ◽

pp. 78-85 ◽

Cited By ~ 38

Author(s):

N. Biglia ◽

Riccardo Torta ◽

R. Roagna ◽

F. Maggiorotto ◽

F. Cacciari ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Low Dose ◽

Hot Flushes ◽

Venlafaxine Hydrochloride

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Nonhormonal Hot Flash Management for Breast Cancer Survivors: A Systematic Review and Network Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/4243175 ◽

2020 ◽

Vol 2020 ◽

pp. 1-13

Author(s):

Jian Liu ◽

Guangning Nie ◽

Yang Li ◽

Zehuai Wen ◽

Liming Lu ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Meta Analysis ◽

Hot Flashes ◽

Controlled Trials ◽

Cochrane Central Register ◽

General Effect ◽

Hot Flash

Aim of the Study. Hot flashes impair the quality of life of breast cancer survivors. Nonhormonal management is an important consideration. The objective of this network meta-analysis (NMA) is to compare the therapeutic efficacy and safety of nonhormonal hot flash treatments for breast cancer survivors. Materials and Methods. We conducted a systematic literature search in PubMed, Cochrane Central Register of Controlled Trials, Embase, Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Wan Fang, and VIP up to May 2018. Randomized controlled trials (RCTs) reporting nonhormonal hot flash treatments for breast cancer survivors were included. Primary outcome measurements were hot flash frequency and hot flash score of posttreatment. The methodological quality of each study was assessed with Cochrane’s risk of bias tool. Results. 16 RCTs involving 2,349 participants were included. The nonhormonal therapies used in the included studies were classified as follows: lifestyle changes, mind-body techniques, dietary/supplements, SSRIs/SNRIs, other medications, and other therapies. Pairwise meta-analysis showed that the general effect of nonhormonal management was statistically more effective than no treatment/placebo/sham in reducing hot flash frequency (SMD = −0.60, 95% CI [−1.13, −0.06]; P=0.03)) and hot flash score (SMD = −0.38, 95% CI [−0.68, −0.08]). For hot flash frequency, results from the NMA showed that there was no statistically significant difference between any two of the nonhormonal treatments. Another NMA result indicated that acupuncture (other therapies) was 16.05 points more effective in reducing hot flash scores than no treatment/waitlist (SMD = −16.05, 95% CI [−30.2, −1.99]). These results were statistically significant. Acupuncture was also ranked the optimal nonhormonal therapy for both hot flash frequency and hot flash score. The safety analysis showed that there were few related adverse events during acupuncture and that drug related adverse reactions could have also occurred in studies using drug interventions Conclusions. This network meta-analysis comparing nonhormonal treatments suggested that acupuncture might be more effective in improving hot flashes for breast cancer survivors. A pronounced placebo response was found during hot flash treatments. The evidence of safety for nonhormonal therapies was also insufficient. Therefore, at present, we cannot make confirmative recommendations of nonhormonal hot flash management for breast cancer survivors. This study is registered with PROSPERO (CRD42018082008).

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