Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

NCT06174259 | Unknown DMC

• 1 other identifier: 1998DRXVTF
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Breast Cancer; Intermittent Fasting

Keywords

locally advanced breast cancer; HR positive HER2 negative breast cancer; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The percentage of patients with grade III/IV toxicity

  6 months

• Grade I/II side effects of chemotherapy

  6 months

• Clinical response

  6months

• Body composition changes (fat, muscles, water)

  6 months

• Inflammatory response to chemotherapy.

  6 months

Study Arms (2)

Intermittent fasting

EXPERIMENTAL

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

regular diet

NO INTERVENTION

Regular diet around standard neoadjuvant chemotherapy

Interventions

intermittent fasting OTHER

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

Intermittent fasting

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Central Study Contacts

Yostena Mekhail, MD

CONTACT

800-545-5557; youstena.kamel@med.menofia.edu.eg

Eman Abdelrazek, MD

CONTACT

800-543-5556; eman.tawfeek@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)