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Water-Only Fasting for the Improvement of Side Effects in Patients with Stage I-III Breast Cancer Receiving Chemotherapy, GAMMER Trial
Trial Status: active
This clinical trial studies the feasibility of water-only fasting in improving side effects of chemotherapy in patients with stage I-III breast cancer. Many people diagnosed with early stage breast cancer (ESBC) will receive whole body therapy consisting of chemotherapy, which is toxic to living cells. Patients may not complete therapy or lower their dose of chemotherapy because there are therapy-related toxicities and side-effects. Water-only fasting may be able to prevent the toxic effects of stress and chemotherapy without causing chronic weight loss.
Inclusion Criteria
Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast
Planning for standard neoadjuvant or adjuvant chemotherapy
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)
Body mass index (BMI) ≥ 19.5 kg/m^2 (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/m^2
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, carbamazepine, cimetidine, diclofenac, doxycycline, fenofibrate, fludrocortisone, glyburide, hydrocortisone, iron supplements, ketorolac, lithium, methylprednisolone, naproxen, niacin, potassium salts, prednisone, procainamide, sevelamer, sulfasalazine, trazodone, valproic acid
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06536881.
I. To determine the feasibility of water-only fasting during chemotherapy in participants with invasive ESBC receiving cytotoxic chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the rate of any high-grade adverse effects (severe/very severe) during chemotherapy.
II. To evaluate the rate of high-grade (grade 3 and 4) hematologic toxicities (neutropenia, anemia, thrombocytopenia) during chemotherapy.
III. To evaluate the total number of dose reductions or delays.
IV. To evaluate quality of life (QoL) and fatigue through patient reported outcomes (PROs) questionnaire (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30]) and Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue with each cycle of chemotherapy.
V. To compare the mean change in QoL score and fatigue in individuals whose labs are consistent with fasting (elevated b-hydroxybutyrate, low insulin, glucose and IGF-1) versus individuals whose labs are inconsistent with fasting.
VI. To compare changes in key inflammatory cytokines/chemokines (IL4, IL6, IL22, IL17, CXCL5, and CXCL11), adipokines (leptin, adiponectin, lipocalin, RBP4, resistin, ghrelin, and omentin) from baseline to after each fast.
VII. To compare changes in tumor cells (AMPK, TSC1/2, STK11, mTOR) and intratumoral b-hydroxybutyrate from baseline to after each fast (if receiving neoadjuvant chemotherapy).
VIII. To examine the modulation of gut microbiome in response to fasting (for cycles 1 and 3) and compare it to baseline composition.
IX. To compare the composition of the gut microbiome from baseline to after fasting (for cycles 1 and 3) in individuals whose labs are consistent with fasting versus individuals whose labs are inconsistent with fasting.
EXPLORATORY OBJECTIVES:
I. To compare the absolute percentage change in Ki-67 and pathologic complete response prior to and following neoadjuvant chemotherapy.
II. To assess prevalence of African American (AA) genotype of Mn superoxide dismutase (MnSOD) in participant with early stage breast cancer and if a greater proportion of women with the AA genotype have fewer side effects and improvement in biomarkers after fasting compared to the women who do not.
OUTLINE: This is a dose-escalation study of water-only intermittent fasting.
DOSE FINDING: Prior to beginning scheduled chemotherapy, patients receive a calendar and instructions for fasting over 24 hours in week 1, 36 hours in weeks 2, and 48 hours in week 3 as tolerated by patients.
CHEMOTHERAPY FASTING: Patients receive a calendar and instructions for water-only fasting over 24, 36, or 48 hours weekly while receiving standard of care (SOC) chemotherapy.
Patients also undergo collection of blood samples throughout the trial.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
