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OpenTrials
Completed

NCT Number: NCT05351021

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

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.

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Key information

Conditions

Peripheral Neuropathy Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

cidophage 850 gm twice daily

Placebo

Drug

placebo twice daily for treatment period

Primary outcomes

  1. The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment

    Time frame: 8 weeks

    Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)

Secondary outcomes

  1. Time to develop grade 2or 3 PIPN

    Time frame: 8 weeks

    The time from randomization till development of grade II or III PN will be recorded for all patients included in the study.

  2. the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale

    Time frame: 8 weeks

    Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale

  3. Pain Severity

    Time frame: 8 weeks

    The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)

  4. Serum biomarkers level in (ng/mL)

    Time frame: 8 weeks

    Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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