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Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether people can follow a water-only fast for 24–48 hours to help them complete 4 rounds of chemotherapy. It is for people with stage I–III breast cancer getting chemotherapy before or after surgery.

This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–III invasive breast cancer, confirmed by a tissue test. Invasive means the cancer has grown into nearby breast tissue.
  • Plan to get 4 rounds of standard chemotherapy called ddAC or TC before or after surgery. Treatment targeting HER2 is also allowed.
  • Have a physical exam by a health care provider within 4 weeks before agreeing to join.
  • Are fully active or can do light work despite some limits on hard physical activity.
  • Have a body mass index (BMI) of at least 19.5. BMI is a measure based on height and weight.
  • Are willing to change your diet and give stool samples 3 times during the study.

Who can't join

  • Have a BMI below 19.5.
  • Have diabetes.
  • Have ever had an eating disorder.
  • Have a serious or uncontrolled health problem, such as kidney failure needing dialysis, severe liver scarring, uncontrolled high blood pressure, or a seizure disorder.
  • Have had weight-loss surgery.
  • Are pregnant or breastfeeding.
  • Take medicines that must be taken with food.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast * Planning for standard neoadjuvant or adjuvant chemotherapy ddAC or TC for 4 cycles (concurrent anti-HER2 therapy is permitted) * Provider physical exam within 4 weeks of consent * Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider) * BMI ≥ 19.5 kg/m2 (as per most recent visit documented in medical record) * Willingness to change diet, and provide fecal sample 3 times during study Exclusion Criteria: * BMI \<19.5 kg/m2 * Diabetes * History of eating disorder * Serious/uncontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery) * Pregnant or nursing * Use of medications that must be taken with food: allopurinol, aspirin, amiodarone, baclofen, bromocriptine, carvedilol, carbamezpine, cimetidine, diclofenac, doxycycline, fenofibrate, fludrocortisone, glyburide, hydrocortisone, iron supplements, ketorolac, lithium, methylprednisolone, naproxen, niacin, potassium salts, prednisone, procainamide, sevelamer, sulfasalazine, trazodone, valproic acid

Study sites (1)

DC