Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Menoufia University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- pathological response rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
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.
Intervention: intermittent fasting (Other)
regular diet
Regular diet around standard neoadjuvant chemotherapy
Outcomes
Primary Outcomes
pathological response rate
Time Frame: 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
- Clinical response(6months)
- Long term efficacy of treatment(5 years)
- Body composition changes (fat, muscles, water)(6 months)
- Inflammatory response to chemotherapy.(6 months)
- The percentage of patients with grade III/IV toxicity(6 months)
- Grade I/II side effects of chemotherapy(6 months)
Investigators
yostena nagy kamel mekhail
Dr
Menoufia University