Status:
RECRUITING
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
Lead Sponsor:
Menoufia University
Conditions:
Locally Advanced Breast Cancer
Intermittent Fasting
Eligibility:
FEMALE
18+ years
Phase:
NA
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 aga...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06174259
Start Date
June 1 2023
End Date
June 1 2025
Last Update
February 1 2024
Active Locations (1)
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1
Menoufia university
Shibīn al Kawm, Menoufia, Egypt, 32511