Study of Metformin drug to prevent numbness of hand and feet caused by cancer injections
Phase 2
- Conditions
- Health Condition 1: C00-D49- Neoplasms
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of grade 2 neuropathy by CTCAE grading ver 5. and /or a total neuropathy score (TNSc)Timepoint: 18 weeks
- Secondary Outcome Measures
Name Time Method 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