Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Development of grade 2 neuropathy by CTCAE grading ver 5. and /or a total neuropathy score (TNSc)Timepoint: 18 weeks | — |
Secondary
| Measure | Time 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
Jawaharlal Institute of Postgraduate Medical Education and Research