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Metformin and Nightly Fasting in Women With Early Breast Cancer

NCT05023967 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-05

No results posted yet for this study

Summary

This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight.

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Breast Ductal Carcinoma In Situ
  • Invasive Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood and tissue samples

DRUG

Extended Release Metformin Hydrochloride

Given PO

OTHER

Monitoring

Use continuous glucose monitoring system

OTHER

Nutritional Assessment

Receive nutritional counseling

OTHER

Short-Term Fasting

Perform intermittent fasting

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Parijatham Thomas, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2025-12-09
Completion
2026-12-16
FDA Drug
Yes

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023967 on ClinicalTrials.gov