Intermittent Fasting, Locally Advanced Breast Cancer
Conditions
Keywords
locally advanced breast cancer, HR positive HER2 negative breast cancer, intermittent fasting
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.
Interventions
OTHERintermittent fasting
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological response rate | 6months | Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade I/II side effects of chemotherapy | 6 months | Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Clinical response | 6months | Radiological before and after the NACT (neoadjuvant chemotherapy) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 |
| The percentage of patients with grade III/IV toxicity | 6 months | Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Inflammatory response to chemotherapy. | 6 months | CRP level |
| Long term efficacy of treatment | 5 years | (DFS, OS) |
| Body composition changes (fat, muscles, water) | 6 months | using Bioimpedance analysis (BIA) assessment before, 3months and at the end of NACT |
Countries
Egypt
Contacts
Primary ContactYostena Mekhail, MD
Backup ContactEman Abdelrazek, MD
Outcome results
None listed