Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Metformin: Oral Metformin : 1 tablet (500mg) PO twice daily for 7 days followed by 1 tablet (850mg) PO twice daily till end of study (3 weeks post last cycle of taxane)
Control Interven
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 years or above 2.Planned to receive paclitaxel for breast cancer either in the adjuvant or neoadjuvant setting 3.Patients planned for four or more cycles of paclitaxel therapy in Breast cancer with 175 mg per m2 every 2 weeks 4.Eastern Cooperative Oncology Group (ECOG) performance status 0 2 5.Planned to initiate paclitaxel within 14 days of randomization 6.No pre existing history of diabetes mellitus 7.Patient willing to participate in the study and to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Evidence of pre-existing peripheral neuropathy on clinical examination or nerve conduction studies 2. Prior therapy with taxanes (paclitaxel or docetaxel) 3. Conditions that impair neurocognitive function or may complicate evaluation during study treatment 4. Concurrent, prior (within 1 month of chemotherapy initiation), or planned use of agents used for neuropathic symptoms (example: tricyclic anti-depressants, pregabalin, duloxetine, etc.) 5. History of allergic or anaphylactic reaction with metformin 6. Patients already receiving oral metformin for other indications 7. Concurrent illnesses that may hinder a patient s ability to undergo protocol-mandated procedures with reasonable safety 8. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare proportion of patients developing clinically significant peripheral neuropathy (incidence of NCI CTCAEv5.0 grade 2 or higher peripheral neuropathy) in patients receiving metformin or placebo during chemotherapy for localised breast cancerTimepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day 1 of last cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare all grades of peripheral neuropathy (proportion) in both arms Timepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day 1 of last cycle;To compare Change in ulnar/median/sural nerve conduction velocity (compared to baseline) and 3 months after therapy cessation (percentage change) in both arms Timepoint: Baseline: Within 3 days before day 1 of cycle 1 Three months after therapy cessation;To compare Time to develop peripheral neuropathy (days) in both arms Timepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day 1 of last cycle;To compare Patient-reported outcomes using the EORTC QLQ-CIPN20 questionnaire in both arms Timepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day 1 of last cycle;To compare Patient-reported outcomes using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx) in both arms Timepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day 1 of last cycle;To compare Patient-reported outcomes using the Functional Assessment of Cancer Therapy-Taxane (FACT-T) in both armsTimepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day 1 of last cycle;To compare incidence of Taxane associated acute pain syndrome ( T-APS) in both arms Timepoint: Baseline: Within 3 days before day 1 of cycle 1 On treatment: Within 3 days before day 1 of cycles 2- 4 End of study: Within 3 days before/ after 4 weeks after day | — |
Countries
India
Contacts
Public ContactDr Akash Kumar
AIIMS, New Delhi
Outcome results
None listed