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MGF 2024-08-08 ClinicalTrials

Water-only fasting feasibility for 24-48 hours assessed in breast cancer patients receiving chemotherapy.

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Background

Breast cancer treatment often involves cytotoxic chemotherapy, which, while effective, is associated with significant adverse effects that can impact patient quality of life and treatment adherence. Preclinical models suggest that cyclic fasting or Fasting Mimicking Diets (FMD) can enhance chemotherapy efficacy by sensitizing cancer cells while protecting normal tissues and stimulating antitumor immunity. This approach modulates growth factors and intracellular nutrient sensing systems, diverting energy from growth to maintenance. This study aims to translate these preclinical observations into a clinical setting, addressing the need for strategies to improve chemotherapy delivery and patient tolerance.

Study Design

This Phase 2/3 clinical trial (NCT02126449) enrolled 131 patients with HER2-negative breast cancer receiving neoadjuvant or adjuvant chemotherapy. Participants underwent 24-48 hours of water-only fasting before or after 4 cycles of chemotherapy. The primary objective was to assess the feasibility of this fasting regimen and its impact on chemotherapy delivery. Secondary endpoints included evaluating changes in adverse effects, various metabolic markers, and the gut microbiome. The study design aimed to determine if short-term fasting could improve patient tolerance and therapeutic outcomes without compromising safety.

Results

The study was designed to rigorously evaluate the feasibility of 24-48 hours of water-only fasting as an adjunct to chemotherapy in 131 breast cancer patients. Researchers aimed to determine if this dietary intervention could improve the delivery of 4 cycles of chemotherapy by mitigating adverse effects and modulating key metabolic markers. The investigation also included an assessment of changes in the gut microbiome, a factor increasingly recognized for its role in cancer treatment response and side effects. While the abstract confirms the study's completion (2018-11), it does not provide specific quantitative results regarding feasibility, adverse effect reduction, or biomarker modulation. The findings are anticipated to shed light on the clinical translatability of preclinical data suggesting fasting-induced protection of normal tissues and enhanced antitumor effects. > The primary objective was to test the feasibility of integrating short-term water-only fasting into standard breast cancer chemotherapy regimens.

Why It Matters

If successful, this research could significantly impact breast cancer treatment protocols by offering a simple, non-pharmacological strategy to improve chemotherapy tolerability and potentially efficacy. Integrating 24-48 hour water-only fasting could reduce chemotherapy side effects, allowing patients to complete more cycles or receive higher doses, thereby improving overall treatment outcomes. This could lead to a practical, patient-empowering protocol that enhances the therapeutic index of existing chemotherapies. The findings, once published, will be crucial for guiding clinical recommendations on dietary interventions during cancer treatment, potentially establishing fasting as a valuable adjunct.


Source: clinicaltrials:NCT06536881 · Ingested 2026-06-17 · Digest: gemini-2.5-flash