NCT05351021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

April 14, 2022

Last Update Submit

March 7, 2023

Conditions

Peripheral NeuropathyBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to develop grade 2or 3 PIPN

    8 weeks

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

    8 weeks

  • Pain Severity

    8 weeks

  • Serum biomarkers level in (ng/mL)

    8 weeks

Study Arms (2)

Group I (metformin group)

EXPERIMENTAL

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

Drug: Metformin

Group II (control group)

PLACEBO COMPARATOR

who will receive adjuvant weekly paclitaxel.

Drug: Placebo

Interventions

MetforminDRUG

cidophage 850 gm twice daily

Group I (metformin group)
PlaceboDRUG

placebo twice daily for treatment period

Group II (control group)

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

  • Bakry HM, Mansour NO, ElKhodary TR, Soliman MM. Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2023 Jul 31;14:1181312. doi: 10.3389/fphar.2023.1181312. eCollection 2023.

    PMID: 37583905DERIVED

MeSH Terms

Conditions

Peripheral Nervous System DiseasesBreast Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 28, 2022

Study Start

April 12, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

EG(1)