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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.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/03/002483
Enrollment
100
Registered
2012-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Recurrent Epithelial Ovarian Cancer

Interventions

Intervention1: metformin: Dose - 500 mg twice daily orally for one year Control Intervention1: placebo(starch powder): Dose - 500 mg twice daily orally for one year

Sponsors

Dr Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of recurrent epithelial ovarian cancer Age more than 18 years and up to 70 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
prolonging progression free survivalTimepoint: patients will be followed for 1 year and time to relapse will be noted

Secondary

MeasureTime frame
i) To evaluate response rate in two arms ii) To study the toxicity profile in two groups iii) To evaluate overall survival in two groups iv) To compare the Quality of life between two groups Timepoint: 1 year

Countries

India

Contacts

Public ContactSaphalta Baghmar
drbsaphalta@gmail.com9811446828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026