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

Primary Purpose

Peripheral Neuropathy, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I (metformin group)

Group II (control group)

Arm Description

who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.

who will receive adjuvant weekly paclitaxel.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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
Pain Severity
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Serum biomarkers level in (ng/mL)
Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits.

Full Information

First Posted
April 14, 2022
Last Updated
March 7, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05351021
Brief Title
Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Official Title
Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (metformin group)
Arm Type
Experimental
Arm Description
who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.
Arm Title
Group II (control group)
Arm Type
Placebo Comparator
Arm Description
who will receive adjuvant weekly paclitaxel.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
cidophage 850 gm twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo twice daily for treatment period
Primary Outcome Measure Information:
Title
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
Description
Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Time to develop grade 2or 3 PIPN
Description
The time from randomization till development of grade II or III PN will be recorded for all patients included in the study.
Time Frame
8 weeks
Title
the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale
Description
Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale
Time Frame
8 weeks
Title
Pain Severity
Description
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Time Frame
8 weeks
Title
Serum biomarkers level in (ng/mL)
Description
Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

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

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