Levetiracetam for the treatment of hot flashes: A pilot study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9116-9116
Author(s):  
S. L. Thompson ◽  
A. Bardia ◽  
A. Tan ◽  
D. Barton ◽  
L. Kottschade ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Pilot Study ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Estrogen Therapy ◽  
Active Agent ◽  
Study Drug ◽  
Hot Flash ◽  
Increased Risk

9116 Background: Hot flashes affect 75 % to 90 % of women transitioning to menopause and are a major cause of morbidity among breast cancer survivors. Levetiracetam, a popular anticonvulsant, is a centrally active agent that anecdotally appeared to reduce hot flashes in clinical practice. This phase II trial sought to evaluate the efficacy of levetiracetam in reducing hot flashes among women with a history of breast cancer or women who did not wish to take estrogen therapy for fear of an increased risk of breast cancer. Methods: Women who were experiencing bothersome hot flashes (≥ 14 times per week, for ≥ 1 month) were eligible. A single arm pilot study design based on previous work was used with a planned sample size of 30 patients. The patients did not receive any study medication during the first week (baseline week). At the beginning of the second week, patients were started on levetiracetam (500 mg), and were to increase the dose by 500 mg each week to a goal of 1,000 mg twice daily. Hot flash diaries were completed daily. The primary endpoint was hot flash score (frequency times average severity). The change from week 1 (baseline) to week 5, the last treatment week, was analyzed by paired t-test and related Wilcoxon procedures. Results: A total of 30 women were enrolled onto this study in eight months. All patients were eligible. 19 women completed all 4 weeks of the study treatment and provided complete data. After treatment with levetiracetam for 4 weeks, mean hot flash scores were reduced by 57% (95% CI 39%-75%), while mean hot flash frequencies were reduced by 53% (95% CI 38%-68%), reductions being greater than what would be expected with a placebo. There were significant improvements, compared to baseline week data, in sweating, hot flash distress, and satisfaction with hot flash control. Eight subjects stopped the study drug due to treatment related adverse events (grade I/II), with the most frequently reported being somnolence, fatigue and dizziness. Conclusions: While levetiracetam appears to be a promising therapy for the treatment of hot flashes, further study is needed to better substantiate the toxicity and efficacy of this drug before it can be more definitively recommended for use in clinical practice. No significant financial relationships to disclose.

Comparison of hypnotherapy versus gabapentin in the treatment of hot flashes: A pilot study.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 168-168
Author(s):  
S. MacLaughlan ◽  
S. Salzillo ◽  
P. Bowe ◽  
S. Scuncio ◽  
B. Malit ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Perceived Risk ◽  
Hot Flashes ◽  
Prospective Trial ◽  
Median Number ◽  
Personal History ◽  
Hot Flash ◽  
Increased Risk ◽  
History Of

168 Background: The purpose of this study is to compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in women with an increased risk or personal history of breast cancer. Methods: In a prospective trial, eligible women were randomized to receive gabapentin (control arm) or hypnotherapy (experimental arm). Eligibility was defined by a personal history of breast cancer or an increased risk of developing breast cancer in women who reported at least one daily hot flash. The duration of participation was eight weeks, and women were asked to keep a daily journal of the number and severity of their hot flashes. The primary endpoints were number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was quality of life, measured using the Hot Flash Related Daily Interference Score (HFRDIS). Results: Twenty-seven women were enrolled (n=14 gabapentin, n=13 hypnotherapy) and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrollment was 4.5 in the gabapentin arm, and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After eight weeks, the median number of daily hot flashes was reduced by 33.3% among women in the gabapentin arm, and 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm, and 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and 55.2% in the hypnotherapy group. Conclusions: Hypnotherapy and gabapentin both demonstrate efficacy in improving hot flashes in women with an increased risk or personal history of breast cancer. Complementary and alternative medicine (CAM) therapies are preferable to many women over hormone therapy due to the perceived risk of breast cancer, but objective data have been lacking comparing its use to conventional therapies. This pilot study provides evidence supporting the use of hypnotherapy for the treatment of hot flashes and emphasizes the need to perform further studies aimed at defining evidence-based recommendations for CAM.

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.

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

1998 ◽  
Vol 16 (7) ◽  
pp. 2377-2381 ◽  
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.

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]

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

2010 ◽  
Vol 28 (35) ◽  
pp. 5147-5152 ◽  
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.

scholarly journals Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

BMJ Open ◽  
2013 ◽  
Vol 3 (9) ◽  
pp. e003138 ◽  
Author(s):  
Shannon MacLaughlan David ◽  
Sandra Salzillo ◽  
Patrick Bowe ◽  
Sandra Scuncio ◽  
Bridget Malit ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Randomised Controlled

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

1998 ◽  
Vol 16 (2) ◽  
pp. 495-500 ◽  
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.

Bridging to survivorship in breast cancer: Learning how treatment impacts mental health among early-stage breast cancer survivors.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9604-9604
Author(s):  
Debra A. Patt ◽  
Janet L. Espirito ◽  
Brian Turnwald ◽  
Robyn K. Harrell ◽  
Debajyoti Bhowmik ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Mental Health ◽  
Breast Cancer Survivors ◽  
Early Stage ◽  
Hot Flashes ◽  
Large Network ◽  
Increased Risk ◽  
Planning Methods ◽  
Ct Utilization ◽  
Survivorship Care Planning

9604 Background: Depression (D) and anxiety (A) complicate survivorship in breast cancer (BC) patients (pts). The prevalence of D and A after BC treatment (Tx) in the community and concordance with BC Tx type is poorly described, but vitally important to characterize risks of Tx and optimize support for BC pts and goals for survivorship care planning. Methods: We queried the electronic health record (EHR), iKnowMed, from a a large network of community oncology practices for pts treated with stage I-III breast cancer from 2007-2010 with at least 5 visits and follow up through 2012 for our retrospective study. We excluded pts who developed metastatic disease or died. We stratified pts by chemotherapy (CT) utilization (yes/no),hormone receptor (HR) status, age, and documented body mass index (BMI) at diagnosis, and post diagnosis development of D (y/n), A (y/n) or utilization of venlafaxine (E) like antidepressants (Ads), non-E like Ads or anti-A medications within the study period. Time to onset of A or D was analyzed using Cox proportional hazard methodology. Results: We identified 8,506 patients with a documented BMI at 1, 2, and 3 years (yrs) post diagnosis. 4369(51%) of patients received adjuvant CT and 4137 (49%) did not. Baseline characteristics were similar between tx groups, and active D or A was low at the time of dx, but as a whole rose to 41% during the study period. Pts with pre-existing D or A at the time of diagnosis were excluded. CT increases the risk of D or A (HR: 1.23, CI: 1.15-1.33). HR+ status also increases the risk of D or A (HR: 1.21, CI:1.11-1.32). Age conveyed a small diminished risk of D or A (HR: 0.98, CI: 0.98-0.99) while baseline BMI conveyed a small increased risk (HR: 1.02, CI 1.01-1.3). When excluding E like compounds that are often used to treat hot flashes in BC pts, CT was still found to have an increased risk of D or A (HR: 1.28, CI: 1.18-1.39), and HR+ was still associated with higher risk of D or A as well (HR: 1.11, CI: 1.01-1.22). Conclusions: Mental health disorders such as D and A are common among BC survivors, and more prevalent among BC survivors who received CT and have HR+ disease. This warrants further investigation on how to evaluate and support the mental health needs of BC survivors.

scholarly journals Weight gain is associated with increased risk of hot flashes in breast cancer survivors on aromatase inhibitors

2010 ◽  
Vol 124 (1) ◽  
pp. 205-211 ◽  
Author(s):  
H. Irene Su ◽  
Mary D. Sammel ◽  
Erin Springer ◽  
Ellen W. Freeman ◽  
Angela DeMichele ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Weight Gain ◽  
Cancer Survivors ◽  
Aromatase Inhibitors ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Increased Risk
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