Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
NCT Number: NCT06536881
Acronym: GAMMER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Early-stage Breast Cancer
Interventions: BEHAVIORAL: Fasting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: The Commonwealth Fund|Maryland Cigarette Restitution Fund
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-08
Completion Date: 2029-05
Locations: Sibley Memorial Hospital, Washington, District of Columbia, 20016, United States

Summary:
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.

Primary Outcome Measures: Proportion of participants with self-reported adherence to the fasting regimen, Determine the feasibility of water-only fasting during chemotherapy in patients with invasive ESBC receiving cytotoxic chemotherapy., 6 -8 months
Secondary Outcome Measures: Rate of high-grade adverse effects, Evaluate the rate of any high-grade adverse effects (severe/very severe) during chemotherapy, 6-8 months|Rate of Hematologic Toxicities, Evaluate the rate of high-grade hematologic toxicities during chemotherapy, 6-8 months|Number of Dose Reductions or Dose Delays, Evaluate the total number of dose reductions or delays, 6-8 months|Percent Change in Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 score, Participants will complete the Quality of Life Questionnaire C30 The Quality of Life Questionnaire-C30, which includes 30 items. The 30 items assess physical, role, emotional, cognitive and social functioning, global health status or Quality Of Life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The Quality of Life Questionnaire-C30 is scored on the basis of classical test theory (CTT), and uses the total item score as the scale score. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). The percent change in Patient Reported Outcome scores from baseline is accessed at 6 and 12 months., 6 months, 12 months|Percent change in Functional Assessment of Chronic Illness Therapy-Fatigue Scale, Participants will complete the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) which includes 13 items. The 13 items assess self-reported fatigue and its impact upon daily activities and function. Response scale is 5 point Likert-type scale with manual scoring template, some items are reverse scored. Scale range is 0 to 52 with O being most fatigue and 52 indicating no fatigue. The percent change in fatigue scores from baseline is accessed at 6 and 12 months., 6 months, 12 months|Changes in Key Inflammatory Cytokines/Chemokines, Compare changes in key inflammatory cytokines/chemokines (IL4, IL6, IL22, IL17, CXCL5, and CXCL11), adipokines (Leptin, Adiponectin, Lipocalin, retinol-binding protein 4 (RBP4), Resistin, Ghrelin, and Omentin) from baseline to after each fast, Baseline, 6-8 months|Compare Changes in Tumor Cells, Compare changes in tumor cells (AMPK, TSC1/2, STK11, mTOR) and intratumoral b-hydroxybutyrate from baseline to after each fast (if receiving neoadjuvant chemotherapy), Baseline, 6-8 months|Compare Modulation of Gut Microbiome, Examine the modulation of gut microbiome in response to fasting (for cycles 1 and 3) and compare it to baseline composition., Baseline, 6-8 months|Compare the Composition of Gut Microbiome, 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 (elevated b-hydroxybutyrate, low insulin, glucose and insulin like growth factor 1 (IGF-1)), Baseline, 6-8 months
Other Outcome Measures: Absolute Percentage Change in Ki-67, Compare the absolute percentage change in Ki-67 and pathologic complete response prior to and following neoadjuvant chemotherapy, Pre neoadjuvant chemotherapy, post neoadjuvant chemotherapy up to 2 years|Prevalence of AA Genotype, Assess prevalence of AA genotype of MnSOD in patient 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., 1-2 years