To Evaluate the effect of Metformin versus Placebo as an Add-on Therapy in patients with recurrent epithelial ovarian cancer receiving chemotherapy: A double blind randomized controlled clinical trial.
Phase 3
- Conditions
- Health Condition 1: null- Recurrent Epithelial Ovarian Cancer
- Registration Number
- CTRI/2012/03/002483
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients of recurrent epithelial ovarian cancer
Age more than 18 years and up to 70 years
Exclusion Criteria
?Patient with diabetes mellitus
?Patients who have received metformin or another mTOR inhibitor in the last 2 years
?Patients with deranged liver or renal profile
?Patients with known hypersensitivity to metformin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method prolonging progression free survivalTimepoint: patients will be followed for 1 year and time to relapse will be noted
- Secondary Outcome Measures
Name Time Method i)To evaluate response rate in two arms <br/ ><br>ii)To study the toxicity profile in two groups <br/ ><br>iii)To evaluate overall survival in two groups <br/ ><br>iv)To compare the Quality of life between two groups <br/ ><br>Timepoint: 1 year