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

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.

Download Full-text

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

Journal of Clinical Oncology ◽

10.1200/jco.1998.16.7.2377 ◽

1998 ◽

Vol 16 (7) ◽

pp. 2377-2381 ◽

Cited By ~ 183

Author(s):

C L Loprinzi ◽

T M Pisansky ◽

R Fonseca ◽

J A Sloan ◽

K M Zahasky ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Low Dose ◽

Hot Flashes ◽

Daily Diary ◽

Clinical Problem ◽

Baseline Period ◽

Hot Flash ◽

Venlafaxine Hydrochloride

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.

Download Full-text

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.

Download Full-text

Bupropion for Control of Hot Flashes in Breast Cancer Survivors: A Prospective, Double-Blind, Randomized, Crossover, Pilot Phase II Trial

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2012.06.011 ◽

2013 ◽

Vol 45 (6) ◽

pp. 969-979 ◽

Cited By ~ 9

Author(s):

Geila Ribeiro Nuñez ◽

Hélio Pinczowski ◽

Rebecca Zanellato ◽

Lívia Tateyama ◽

Fernanda Schindler ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Phase Ii ◽

Breast Cancer Survivors ◽

Phase Ii Trial ◽

Hot Flashes ◽

Pilot Phase ◽

Double Blind

Download Full-text

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.

Download Full-text