Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

Locally Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174259
• Other study ID #: 1998DRXVTF
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: Yostena Mekhail, MD
• Phone: 800-545-5557
• Email: youstena.kamel[@]med.menofia.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Intermittent Fasting
• Locally Advanced Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Egypt	Menoufia university	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

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