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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05351021
Other study ID # 2021-375
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 12, 2022
Est. completion date October 30, 2022

Study information

Verified date March 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin
cidophage 850 gm twice daily
Placebo
placebo twice daily for treatment period

Locations

Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03) 8 weeks
Secondary Time to develop grade 2or 3 PIPN The time from randomization till development of grade II or III PN will be recorded for all patients included in the study. 8 weeks
Secondary the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale 8 weeks
Secondary Pain Severity The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF) 8 weeks
Secondary Serum biomarkers level in (ng/mL) Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits. 8 weeks
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