Study on Metformin and Nightly Fasting in Women with Early Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05023967

Provider View

This clinical trial is exploring whether a combination of nightly fasting and the diabetes medication metformin can help reduce breast cancer cell growth in women with early-stage breast cancer. The study aims to see if this approach can prevent invasive breast cancer or ductal carcinoma in situ (DCIS).

Patient Parameters

Program Overview

This study is investigating if combining nightly fasting with the diabetes medication metformin can decrease the growth of breast cancer cells and other cancer markers in women with early-stage breast cancer. Metformin is commonly used to treat type II diabetes and has been linked to a lower risk of cancer in diabetic patients. Intermittent fasting might protect cancer patients from the harmful effects of chemotherapy without causing long-term weight loss. The combination of fasting and metformin could potentially slow down breast cancer growth and may be beneficial for women at risk of breast cancer or other cancers related to being overweight.

Description

Primary Objectives:

  • To check the safety of the treatment by monitoring any serious side effects in the first 14 women receiving the treatment.
  • To compare the changes in cancer cell growth markers between women receiving the treatment and those who are not.

Secondary Objectives:

  • To study how the treatment affects certain proteins in cancer tissue.
  • To measure changes in blood markers related to insulin, inflammation, and other factors.
  • To see if genetic changes in cancer cells are linked to treatment response.
  • To compare cell death in cancer samples between treatment groups.
  • To assess safety and side effects using standard criteria.
  • To explore how stress, diet, smoking, and alcohol use affect treatment response.
  • To compare blood sugar levels between treatment groups and different metformin doses.

Study Design:

Participants are divided into two groups:

  • Group 1: Women will fast for at least 16 hours each night and use a glucose monitor for 4-6 weeks. They will receive nutritional counseling and start taking metformin daily from the second week until surgery. Blood and tissue samples will be collected at the start and end of the study.

  • Group 2: Women will continue their usual diet and use a glucose monitor for 4-6 weeks. Blood and tissue samples will be collected at the start and end of the study.

After the study, participants will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Women with confirmed early-stage breast cancer that can be operated on and are not receiving pre-surgery treatment.
  • Women with larger tumors who choose not to have chemotherapy before surgery can also join.
  • Women with certain types of breast cancer (luminal HER2+ve) and DCIS are eligible.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential must agree to use contraception during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Underweight women with a BMI less than 18.5.
  • Women who have had previous breast cancer treatment.
  • Women planning to receive pre-surgery therapy for certain breast cancer types.
  • Women with triple-negative breast cancer.
  • Women with a history of low blood sugar symptoms.
  • Diabetic women or those with high fasting blood sugar levels.
  • Women allergic to metformin.
  • Women taking other experimental drugs.
  • Women with uncontrolled illnesses or psychiatric conditions.
  • Women with a history of lactic acidosis or liver problems.
  • Women with vitamin B12 deficiency.
  • Women using high doses of diuretics.
  • Women using hormonal contraceptives or hormones recently.
  • Women using certain medications like topiramate.
  • Pregnant or breastfeeding women.
  • Women practicing intermittent fasting.
  • Women without support in case of need.

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