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Study of Metformin drug to prevent numbness of hand and feet caused by cancer injections

Efficacy of Metformin in preventing Platinum and/or Taxane induced Peripheral Neuropathy :Double blind, Placebo , Randomized controlled trial - EMPPN trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071960
Enrollment
140
Registered
2024-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Metformin: Dosage used for the study: 500mg twice daily after food Duration: 18 weeks Biguanide Class of medication Mechanism of action: Increases peripheral glucose uptake and utilizat

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients planned for receiving Platinum or Taxane based chemotherapy regimens 2.Planned for a minimum of 18 weeks of chemotherapy 3.Curative or Palliative intent

Exclusion criteria

Exclusion criteria: 1.Patients who have already received Chemotherapy 2.Patients who have previously received neurotoxic or neurmodulating medications ( Gabapentin,Amitrypillie,Pregabalin, etc) 3.Patients already on metformin 4.Patients with pre existing neuropathic conditions 5. Renal Impairment( eGFR less than 60ml/min) Cardiac Failure, Liver Failure 6.Body mass Index less than 18

Design outcomes

Primary

MeasureTime frame
Development of grade 2 neuropathy by CTCAE grading ver 5. and /or a total neuropathy score (TNSc)Timepoint: 18 weeks

Secondary

MeasureTime frame
Change in quality of life using EORTC QLQ CIPN 20 questionaireTimepoint: 18 weeks;Percentage dose reduction in chemotherapeutic drugsTimepoint: Assessed prior to each cycle and at 18 weeks;Time (weeks) to occurrence of grade 2 or more neuropathy using CTCAE grading ver 5. and/or Total Neuropathy score (TNSc)Timepoint: Assessed prior to each cycle and at 18 weeks;Type of neuropathy (Motor, Sensory) using Nerve Conduction studyTimepoint: Assessed prior to each cycle and at 18 weeks

Countries

India

Contacts

Public ContactArvind Bhargav

Jawaharlal Institute of Postgraduate Medical Education and Research

arvi1994@gmail.com9790809889

Outcome results

None listed

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