Water-only fasting to improve chemotherapy for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate the feasibility of implementing 24-48 hours of water-only fasting to enhance the delivery of chemotherapy in patients with early-stage breast cancer. The study focuses on understanding how fasting may mitigate the adverse effects associated with chemotherapy, which often lead to dose reductions or treatment discontinuation. By examining the biological mechanisms behind fasting and its impact on chemotherapy tolerability, the study seeks to provide insights that could improve treatment outcomes for breast cancer patients. A total of 30 patients will be enrolled to assess the safety and effectiveness of this fasting intervention alongside standard chemotherapy regimens.

Why it matters

Who can join: the full rules

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

Where it's running

• Sibley Memorial Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Jennifer Sheng, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Study coordinator: Jennifer Sheng, MD
• Email: jsheng7@jhmi.edu
• Phone: 202-537-4000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using blood-based tumor DNA (ctDNA) to find leftover breast cancer after treatment

  This research will test whether a simple blood test that looks for tiny bits of tumor DNA can tell if people treated for breast cancer (including HR+/HER2-, HER2+, and triple-negative) still have leftover cancer or are at risk of recurrence.

  Recruiting at 16 sites Tempus AI · Birmingham, Alabama and 15 other locations · NCT07211178

• Switching aromatase inhibitors versus guideline-based side-effect care to help with AI side effects

  This test tries switching one aromatase inhibitor to another versus using guideline-based side-effect care to see which helps postmenopausal women with early-stage ER-positive breast cancer stay on their hormone therapy.

  Recruiting Phase 2 Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT07071038

• Radiation therapy for early-stage breast cancer using a shorter treatment schedule

  This study is testing a shorter radiation treatment schedule for women 50 and older with early-stage breast cancer to see if it is safe and effective while reducing the number of visits needed.

  Recruiting Phase 2 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06902311

• Using Biolosion with standard therapy to treat triple-negative breast cancer

  This study is testing if adding a new oral probiotic called Biolosion to standard treatment can help women with locally advanced triple-negative breast cancer have better outcomes.

  Recruiting Phase 2 Sun Yat-sen University · Lanzhou, Gansu and 4 other locations · NCT06768931

• Precision neoadjuvant therapy for operable breast cancer

  This study is testing if a personalized treatment approach using new drugs for operable breast cancer can work better than standard chemotherapy alone.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT05582499

• Screening program for heart and metabolic health in breast cancer survivors

  This study is testing a screening program for women who have survived early-stage breast cancer to see if it helps identify and manage heart and metabolic health risks like diabetes and heart disease.

  Recruiting Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT05386719

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.