Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

NCT06174259 — Not applicable, Unknown, 66 participants, Menoufia University

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Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial

Registry	NCT06174259
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	Menoufia University (Other)
Conditions	Locally Advanced Breast Cancer, Intermittent Fasting
Interventions	intermittent fasting (Other)
Dates	start 2023-06-01, primary completion 2024-06-01 (estimated), completion 2025-06-01 (estimated), first posted 2023-12-18, last updated 2024-02-01
Locations	1 site in Egypt

-Summary

Breast cancer is the most common cancer type among women in Egypt and world. Preclinical studies show fasting reduces growth factors and modulates nutrient sensing systems, protecting normal cells against chemotherapy. However, cancer cells are not protected due to Differential Stress Resistance (DSR), making them more vulnerable to chemotherapeutics. This study aims to evaluate intermittent fasting impact on neoadjuvant chemotherapy in breast cancer patients.

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+Arms and interventions

Arm	Type	Interventions	Description
Intermittent fasting	Experimental	Other: intermittent fasting	16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy.
regular diet	No intervention		Regular diet around standard neoadjuvant chemotherapy

intermittent fasting (Other): 16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)

+Outcome measures

Primary outcomes

pathological response rate [6months]: Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response

Secondary outcomes

The percentage of patients with grade III/IV toxicity [6 months]: Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Grade I/II side effects of chemotherapy [6 months]: Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Clinical response [6months]: Radiological before and after the NACT (neoadjuvant chemotherapy) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Body composition changes (fat, muscles, water) [6 months]: using Bioimpedance analysis (BIA) assessment before, 3months and at the end of NACT
Inflammatory response to chemotherapy. [6 months]: CRP level
Long term efficacy of treatment [5 years]: (DFS, OS)

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer. - Planned to receive standard neoadjuvant chemotherapy.
* Measurable disease (breast and/or lymph nodes).
* WHO performance status 0-2.
* Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2).
* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up

Exclusion Criteria:

* Serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Diabetes Mellitus.
* Pregnancy or lactating
* Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.
* Previous malignancy.
* Using weight loss medication.

+Locations (1)

Facility	City	Country	Status
Menoufia university	Shibīn al Kawm, Menoufia	Egypt	Recruiting