ACTIVE_NOT_RECRUITING

Metformin and Nightly Fasting in Women With Early Breast Cancer

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Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Breast Ductal Carcinoma In SituInvasive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Time Restricted Eating And Metformin (TEAM) in Invasive Breast Cancer (IBC) or Ductal Carcinoma in Situ (DCIS). A Randomized, Phase IIb, Window of Opportunity Presurgical Trial.

Quick Facts

Study Start:2023-04-04
Study Completion:2026-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05023967

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with histologically confirmed luminal (ER+ve and/or progesterone \[PgR\]+ve \>= 1%) operable IBC (cT1-2, cN0-1, Mx) candidate to elective surgery and not to neo-adjuvant treatment. Women with larger tumors who refuse neo-adjuvant chemotherapy before surgery can also be eligible. Luminal HER2+ve (cT1, cN0) IBC and DCIS are also eligible
  2. * Age \>= 18 years
  3. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
  4. * Leukocytes \>= 3,000/microliter
  5. * Absolute neutrophil count \>= 1,500/microliter
  6. * Platelets \>= 100,000/microliter
  7. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal
  8. * Creatinine within normal institutional limits
  9. * Creatinine clearance estimated with Cockcroft-Gault formula \> 45 mL/min
  10. * Female participants of child-bearing potential must agree to use contraception such as barrier method of birth control or abstinence, prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she has to inform her study physician immediately. The effects of metformin hydrochloride extended release on the developing human fetus at the recommended therapeutic dose are unknown
  11. * Ability to understand and the willingness to sign a written informed consent document
  1. * Body mass index (BMI) \< 18.5 Kg/m\^2
  2. * Previous treatment for breast cancer including chemotherapy and endocrine therapy within the last 12 months
  3. * Women who are planned to receive neoadjuvant therapy
  4. * Triple negative breast cancer (BC)
  5. * Patients with a history of cancer within the last year. NOTE: Non melanoma skin cancer is allowed.
  6. * Documented history of symptomatic hypoglycemia
  7. * Diabetic patients or participants with fasting glucose level \>= 126 mg/dL
  8. * Known hypersensitivity or intolerance to metformin hydrochloride extended release
  9. * Participants should not be receiving any other investigational agents
  10. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  11. * History of lactic acidosis
  12. * Liver dysfunction including chronic active hepatitis and cirrhosis not compensated
  13. * History of vitamin B12 deficiency or megaloblastic anemia
  14. * Chronic use of large doses of diuretics (e.g., \> 80 mg furosemide)
  15. * Current use of oral hormonal contraceptives or female hormones in the last four weeks or 5 half-lives, excluding vaginal creams and intrauterine devices (IUDs)
  16. * Concomitant use of topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide)
  17. * Pregnant or lactating women. Pregnant women are excluded from this study because even though published data from post-marketing studies have not reported a clear association between metformin hydrochloride extended release and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin hydrochloride extended release was used during pregnancy, these studies cannot definitely establish the absence of any metformin hydrochloride extended release associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with metformin hydrochloride extended release, breastfeeding should be discontinued if the mother is treated with metformin hydrochloride extended release. Moreover, prolonged fasting is not recommended in pregnant woman
  18. * Women who practice any type of intermittent fasting program
  19. * Women who will not have anyone available to assist them in case of need

Contacts and Locations

Principal Investigator

Parijatham Thomas, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2026-12-16

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2026-12-16

Terms related to this study

Additional Relevant MeSH Terms

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