Venlafaxine versus placebo for treatment of vaso-motor symptoms in gynaecological cancer survivors: A double-blind, randomized, placebo-controlled trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Efficacy of Venlafaxine as compared to placebo on hot flashes in pre- menopausal gynae cancer survivors using 4 category Hot Flush Diary
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •Severe metabolic, thromboembolic or endocrine disease Uncontrolled hypertension Any major psychiatric condition that would confound evaluation Received previous treatment for hot flushes (eg.
Outcomes
Primary Outcomes
Efficacy of Venlafaxine as compared to placebo on hot flashes in pre- menopausal gynae cancer survivors using 4 category Hot Flush Diary
Time Frame: 6weeks,12weeks and 2 weeks follow up
Secondary Outcomes
- 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)
Investigators
Dr Soumi Banerjee
AIIMS, New Delhi