Venlafaxine versus placebo for treatment of vaso-motor symptoms in gynaecological cancer survivors: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Efficacy of Venlafaxine as compared to placebo on hot flashes in pre- menopausal gynae cancer survivors using 4 category Hot Flush Diary
研究概览
简要总结
This study is a randomised , double blind, parallel group trial comparing efficacy of Venlafaxine 37.5mg daily versus placebo administered daily in gynae cancer survivors with vasomotor symptoms for 12 weeks in 64 patients (32 in each group).The study will be conducted in 3 centres of AIIMS , New Delhi ( Gynae Obs Department, NCI-AIIMS, IRCH Clinic).The primary outcome will be to compare the efficacy of Venlafaxine on hot flushes using 4 category hot flush diary at 6 weeks , 12 weeks and 2 weeks follow up..The secondary outcome will be to assess the effect on quality of life using hot flush related daily interference score, assessment of side effects (CTCAE version 5.0), assessment of anxiety and depression by HAM_A and HAM-D ams assessment of metabolic parameters (CBC,LFT, RFT,FBS,Lipid Profile) at 6 weeks, 12 weeks and 2 weeks follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Gynae cancer survivors who have received any form of treatment less than 2 years More than 18 years of age More than 14 hot flushes per week Completed treatment for gynaecological cancer Willing to participate and follow-up without discontinuation during the study period Life expectancy of more than 6month.
排除标准
- •Severe metabolic, thromboembolic or endocrine disease Uncontrolled hypertension Any major psychiatric condition that would confound evaluation Received previous treatment for hot flushes (eg.
结局指标
主要结局
Efficacy of Venlafaxine as compared to placebo on hot flashes in pre- menopausal gynae cancer survivors using 4 category Hot Flush Diary
时间窗: 6weeks,12weeks and 2 weeks follow up
次要结局
- Quality of life(6weeks,12weeks and 2 weeks follow up)
- Side effects(6weeks,12weeks and 2 weeks follow up)
- Depression and anxiety(6weeks,12weeks and 2 weeks follow up)
- Metabolic parameters(6weeks,12weeks and 2 weeks follow up)
研究者
Dr Soumi Banerjee
AIIMS, New Delhi