Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

Menoufia University

Status: Enrolling

Conditions: Locally Advanced Breast Cancer; Intermittent Fasting

Treatments: Other: intermittent fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT06174259

1998DRXVTF

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Intermittent fasting

Experimental group

Description:

16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy.

Treatment:

Other: intermittent fasting

regular diet

No Intervention group

Description:

Regular diet around standard neoadjuvant chemotherapy