Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351021
• Other study ID #: 2021-375
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

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