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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Menoufia university
RECRUITING
Shibīn Al Kawm
Contact Information
Primary
Yostena Mekhail, MD
youstena.kamel@med.menofia.edu.eg
800-545-5557
Backup
Eman Abdelrazek, MD
eman.tawfeek@med.menofia.edu.eg
800-543-5556
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 66
Treatments
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.
No_intervention: regular diet
Regular diet around standard neoadjuvant chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Menoufia University

This content was sourced from clinicaltrials.gov