Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

Not Applicable

Recruiting

• Conditions: Locally Advanced Breast Cancer; Intermittent Fasting
• Interventions: Other: intermittent fasting

• Registration Number: NCT06174259
• Lead Sponsor: Menoufia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent fasting	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Long term efficacy of treatment	5 years	(DFS, OS)

Trial Locations

Locations (1)

Menoufia university; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt