Management of Hot Flashes in Patients Who Have Breast Cancer With Venlafaxine and Clonidine: A Randomized, Double-Blind, Placebo-Controlled Trial

2011 ◽  
Vol 29 (29) ◽  
pp. 3862-3868 ◽  
Author(s):  
Annelies H. Boekhout ◽  
Andrew D. Vincent ◽  
Otilia B. Dalesio ◽  
Joan van den Bosch ◽  
Joke H. Foekema-Töns ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Group Versus ◽  
Primary Objective ◽  
Double Blind ◽  
Hot Flash ◽  
Double Blind Placebo ◽  
History Of ◽  
The Difference

Purpose Therapies for breast cancer may induce hot flashes that can affect quality of life. We undertook a double-blind, placebo-controlled trial with the primary objective of comparing the average daily hot flash scores in the twelfth week among patients treated with venlafaxine, clonidine, and placebo. Additional analyses of the hot flash score over the full 12 weeks of treatment were performed. Patients and Methods In all, 102 patients with a history of breast cancer were randomly assigned (2:2:1) to venlafaxine 75 mg, clonidine 0.1 mg, or placebo daily for 12 weeks. Questionnaires at baseline and during treatment assessed daily hot flash scores, sexual function, sleep quality, anxiety, and depression. Results After 12 weeks, a total of 80 patients were evaluable for the primary end point. During week 12, hot flash scores were significantly lower in the clonidine group versus placebo (P = .03); for venlafaxine versus placebo, the difference was borderline not significant (P = .07). However, hot flash scores were equal in the clonidine and venlafaxine groups. Over the course of 12 weeks, the differences between both treatments and placebo were significant (P <.001 for venlafaxine v placebo; P = .045 for clonidine v placebo). Frequencies of treatment-related adverse effects of nausea (P = .02), constipation (P = .04), and severe appetite loss were higher in the venlafaxine group. Conclusion Venlafaxine and clonidine are effective treatments in the management of hot flashes in patients with breast cancer. Venlafaxine resulted in a more immediate reduction of hot flash scores when compared with clonidine; however, hot flash scores at week 12 were lower in the clonidine group than in the venlafaxine group.

Transdermal clonidine for ameliorating tamoxifen-induced hot flashes.

1994 ◽  
Vol 12 (1) ◽  
pp. 155-158 ◽  
Author(s):  
R M Goldberg ◽  
C L Loprinzi ◽  
J R O'Fallon ◽  
M H Veeder ◽  
A W Miser ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Prospective Study ◽  
Hot Flashes ◽  
Estrogen Therapy ◽  
Crossover Design ◽  
Double Blind ◽  
Hot Flash ◽  
Mouth Dryness ◽  
History Of ◽  
Protocol Study

PURPOSE To determine the efficacy of transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer. PATIENTS AND METHODS A randomized, double-blind, crossover design was used in this prospective study. Women with a history of breast cancer who were receiving tamoxifen and suffering from hot flashes were potentially eligible for this protocol study. RESULTS Clonidine did reduce hot-flash frequency to a degree that was statistically impressive (P < .0001), but clinically moderate (20% reduction from baseline). It also decreased hot-flash severity (P = .02, 10% reduction from baseline). Clonidine was related to increased mouth dryness (P < .001), constipation (P < .02), itchiness under the patch (P < .01), and drowsiness (P < .05). CONCLUSION Better means are needed to alleviate hot flashes among patients in whom estrogen therapy is contraindicated.

A double-blind, randomized cross-over trial of venlafaxine versus clonidine to treat hot flashes in breast cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9083-9083
Author(s):  
C. Mom ◽  
C. Buijs ◽  
P. H. Willemse ◽  
H. Boezen ◽  
J. Maurer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Hot Flashes ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Hot Flash ◽  
History Of ◽  
Loss Of Appetite ◽  
To Receive

9083 Background: Breast cancer patients who become postmenopausal due to their treatment can experience more frequent and severe hot flashes than healthy postmenopausal women. Estrogens are considered to be contra-indicated. Venlafaxine and clonidine are both used to alleviate hot flashes, with different side effects. This study compared side effects, efficacy and patient preference. Methods: In a double-blind, cross-over study women <60 years, with a history of breast cancer, and experiencing at least 14 hot flashes/week were randomized to receive venlafaxine 75 mg od (and placebo bid) for 8 weeks, followed by a 2 week wash-out period, and 8 weeks of clonidine 0.025 mg bid (and placebo od) or vice versa. Hot flash frequency and hot flash score (frequency × severity) were recorded in a diary and side effects were scored using a questionnaire during the 2nd and 8th week of both treatment periods, and these were compared to a baseline week. Results: Sixty patients were randomized to start with venlafaxine (n=30) and clonidine (n=30), 40 completed both treatment periods. Premature treatment discontinuation occurred in 15/59 patients during venlafaxine and in 5/53 during clonidine due to side effects (p<0.05). The main side effects of venlafaxine were nausea and headache, and of clonidine dry mouth. In the 8th week of treatment women reported more loss of appetite (24% vs 4%; p=0.03) and improved sleeping (55% vs 75%; p=0.03) with venlafaxine. A =50% reduction in hot flash score was found in 21 (49%) and 26 (55%) of the patients with venlafaxine and clonidine respectively (ns). The decrease in hot flash score was most marked in the first treatment period. At study completion 20 (33%) of the patients chose to continue clonidine, and 17 (29%) preferred venlafaxine (ns), whereas 23 (38%) declined further treatment. Conclusions: Venlafaxine and clonidine are both moderately and equally effective in the reduction of hot flashes. Side effects are the main reason for discontinuation, occurring more often during treatment with venlafaxine. No significant financial relationships to disclose.

scholarly journals Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial

The Lancet ◽  
2005 ◽  
Vol 366 (9488) ◽  
pp. 818-824 ◽  
Author(s):  
Kishan J Pandya ◽  
Gary R Morrow ◽  
Joseph A Roscoe ◽  
Hongwei Zhao ◽  
Jane T Hickok ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Double Blind ◽  
Double Blind Placebo

Internet based double-blind cross-over clinical trial to test efficacy of high dose isoflavone soy in controlling breast cancer survivor hot flashes

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 636-636 ◽  
Author(s):  
W. C. Dooley ◽  
C. Hendricks ◽  
Y. Gusev ◽  
L. Shockney
Keyword(s):  
Breast Cancer ◽  
Cancer Survivor ◽  
Breast Cancer Survivor ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Time Of Day ◽  
High Dose ◽  
Double Blind ◽  
Hot Flash

636 Background: Severe hot flashes are common after completion of allopathic breast cancer treatment. Hot flashes are rare in the Orient where high isoflavone soy diets are common. Methods: We enrolled breast cancer survivors experiencing hot flashes after the completion of surgery, radiation and chemotherapy into a 16 week double blind cross-over casein placebo controlled trial of a 160 mg isoflavone soy dietary supplement. Hot flash frequency, severity, and time of day, exercise time and patient journaling was recorded by an internet diary placed on a HIPPA compliant server with password access. Results: Of 168 patients enrolled, 117 actually participated in taking supplementation and completing internet diaries giving adequate data for analysis. Of this group 13 patients dropped out of study for failure to finish all dietary supplements throughout the study period. The hot flash data during the last 4 weeks on each supplement was compared to determine benefit. There was no statistical difference in hot flash frequency, intensity or duration between either supplement independent of exercise level. Interestingly, 82% of patients reported a decrease in hot flashes in the first 4 weeks of study independent of which supplement they were randomized to receive. The journal entries report during this “induction” period that the majority of patients had identified emotional or dietary or other triggers for their hot flashes. The avoidance of the triggers seemed to substantially reduce their reported menopausal symptoms. Conclusions: High dose soy isoflavone dietary supplementation is ineffective in reducing breast cancer survivor hot flashes. Journaling may have a benefit in allowing survivors to find their individual triggers for the most severe hot flashes. Internet patient data entry provides a unique and highly compliant tool for obtaining direct patient reporting in survivorship clinical trials. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document