Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

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

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 Overview

• Status: Recruiting
• Conditions: Locally Advanced Breast Cancer; Intermittent Fasting
• Intervention / Treatment: Other: intermittent fasting

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yostena Mekhail, MD; Phone Number: 20+ 800-545-5557; Email: youstena.kamel@med.menofia.edu.eg
• Study Contact Backup: Name: Eman Abdelrazek, MD; Phone Number: 800-543-5556; Email: eman.tawfeek@med.menofia.edu.eg

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32511
      • Recruiting
      • Menoufia University
      • Contact: mary youssef, Ms; Phone Number: +20 800-555-5577; Email: yoyonagy7@gmail.com
      • Principal Investigator: Yostena Mekhail, MD
      • Principal Investigator: Eman Abdelrazek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: intermittent fasting; 16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)
No Intervention: regular diet; Regular diet around standard neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological response rate	Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response	6months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intermittent fasting; locally advanced breast cancer; HR positive HER2 negative breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1998DRXVTF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be published after completing the study in peer reviewed journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No