Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Phase 2 Randomized Controlled Clinical Trial

Study Overview
=================
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.

Official Title
-----------------
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Phase 2 Randomized Controlled Clinical Trial

Conditions
-----------------
Locally Advanced Breast Cancer, Intermittent Fasting

Intervention / Treatment
-----------------
* Other: intermittent fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of pCR. | Assesment of pathological response using the Miller-Payne grading system | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with grade III/IV toxicity | CTCAE v5.0 | 6 months | 
| Grade I/II side effects of chemotherapy | CTCAE v5.0 | 6 months | 
| Clinical response | Radiological before and after the NACT (neoadjuvant chemotherapy) using RECIST1.1 | 6months | 
| Body composition changes (fat, muscles, water) | using inbody test before, 3months and at the end of NACT | 6 months | 
| Inflammatory response to chemotherapy. | CRP level | 6 months | 
| Long term efficacy of treatment | (DFS, OS) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
locally advanced breast cancer, HR positive HER2 negative breast cancer, intermittent fasting