Status:
COMPLETED
Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Lead Sponsor:
Mansoura University
Conditions:
Peripheral Neuropathy
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief Summary
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patien...
Eligibility Criteria
Inclusion
- Adult patients (\>18 years old)
- Early-stage breast cancer patients who will receive adjuvant paclitaxel
- Performance status according to Eastern Cooperative oncology group (ECOG) \< 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine\<1.5 mg/dl).
Exclusion
- Clinical neuropathy at prior to enrollment.
- Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
- Patients with a history of hypersensitivity to metformin.
- Pregnant or lactating females.
- Patients who are using metformin for any other cause.
- Patients with Diabetes mellitus.
- Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy.
- Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05351021
Start Date
April 12 2022
End Date
October 30 2022
Last Update
March 9 2023
Active Locations (1)
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1
Mansoura University
Al Mansurah, Egypt, 35516