Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

NCT06536881 | Recruiting

• 2 other identifiers: J2362IRB00390964
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Early-stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Rate of high-grade adverse effects

  6-8 months

• Rate of Hematologic Toxicities

  6-8 months

• Number of Dose Reductions or Dose Delays

  6-8 months

• Percent Change in Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 score

  6 months, 12 months

• Percent change in Functional Assessment of Chronic Illness Therapy-Fatigue Scale

  6 months, 12 months

Other Outcomes (2)

• Absolute Percentage Change in Ki-67

  Pre neoadjuvant chemotherapy, post neoadjuvant chemotherapy up to 2 years

• Prevalence of AA Genotype

  1-2 years

Study Arms (1)

Fasting prior to chemotherapy

EXPERIMENTAL

Prior to chemotherapy administration, a trial of a 24-hour water-only fast will be conducted; at least 1 successful 24-hour fast is required to proceed with the fasting intervention during chemotherapy. A total of 3 trials is allowed (for a maximum of 48 hours fasting).

Behavioral: Fasting

Interventions

Fasting BEHAVIORAL

The dietician will review the patient's chemotherapy schedule, and confirm the fasting window (as windows may be 24, 26 or 48 hours; and chemotherapy start times can vary from patient to patient).

Fasting prior to chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with early stage breast cancer (HER2-negative) planning to receive chemotherapy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• The Commonwealth Fund: collaborator
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Sheng, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Sheng, MD

CONTACT

202-537-4000; jsheng7@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants undergo a trial of 24-hour water only fasting before starting chemotherapy. At least one successful 24-hour fast is required. A total of 3 trials can be attempted. Participants can also progressively increase by 12 hours each week as tolerated or to a max of 48 hours. If a participant is unable to maintain at least a 24-hour fast during the study, participation in this study will end. Once the tolerated fasting time is established, this will be the starting fasting regimen used for Cycle 1 of 4 of the scheduled chemotherapy. Investigators also aim to understand the impact of fasting on quality of life, inflammatory markers, and the bacteria in the gut. Participants will complete surveys weekly, blood samples for research and fasting labs with each cycle of chemotherapy (at 4 different time points). Investigators will also collect research bloods at baseline, stool samples 3 times in the study: baseline, and after fasting interventions for Cycle 1 and 3.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)