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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)
Menoufia university
Shibīn al Kawm, Menoufia, Egypt
RECRUITINGpathological 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
Time frame: 6months
The percentage of patients with grade III/IV toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 6 months
Grade I/II side effects of chemotherapy
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 6 months
Clinical response
Radiological before and after the NACT (neoadjuvant chemotherapy) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Time frame: 6months
Body composition changes (fat, muscles, water)
using Bioimpedance analysis (BIA) assessment before, 3months and at the end of NACT
Time frame: 6 months
Inflammatory response to chemotherapy.
CRP level
Time frame: 6 months
Long term efficacy of treatment
(DFS, OS)
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.