Venlafaxine and gabapentin for the management of hot flashes in breast cancer survivors: a randomized crossover trial

Canadian Breast Cancer Foundation0 个研究点目标入组 120 人开始时间: 2006年6月5日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Women with a history of breast cancer, ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) (currently without evidence of malignant disease and who have completed chemotherapy or radiation therapy for 8 weeks)
•2. Age 18 or above
•3. Bothersome hot flashes (at least 14 hot flashes per week and of sufficient severity for the patients to desire pharmacologic intervention)
•4. Presence of hot flashes for at least one month prior to study entry
•5. Life expectancy of at least six months
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
•7. Normal creatinine clearance

•1. Previous use of venlafaxine or the use of any other antidepressants (including St. John's Wort) within a year prior to study entry
•2. Current (less than or equal to 2 weeks) or planned use of other agents for the treatment of hot flashes
•3. Calcium channel antagonist or gabapentin within two weeks of study entry
•4. Tamoxifen, aromatase inhibitors and gonadotropin-releasing hormone (GnRH) analogues are allowed unless started less than or equal to 4 weeks and or if the plan is to stop these agents during the study period (i.e. 12 weeks)

发起方

Canadian Breast Cancer Foundation