Recruiting

Observational Study

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06536881

Conditions

Breast Cancer

Early-stage Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fasting

Study Details

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

Study ID

NCT06536881

Start date

Aug 8, 2024

Status verified date

Aug, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fasting prior to chemotherapy

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).

Interventions

Fasting

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).

Primary outcome measure

  • Proportion of participants with self-reported adherence to the fasting regimen [ Time Frame: 6 -8 months ]

Central Contacts and Locations

Central contacts

Jennifer Sheng, MD

202-537-4000jsheng7@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

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

Contacts

Azka Tariq

202-660-5712atariq6@jhmi.edu

Aliya Lalji

202-243-2294alalji1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-08-21.