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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent fasting | Experimental | 16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy. |
|
| regular diet | No Intervention | Regular diet around standard neoadjuvant chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent fasting | Other | 16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with grade III/IV toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 6 months |
| Grade I/II side effects of chemotherapy | Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yostena Mekhail, MD | Contact | 800-545-5557 | 20+ | youstena.kamel@med.menofia.edu.eg |
| Eman Abdelrazek, MD | Contact | 800-543-5556 | eman.tawfeek@med.menofia.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia university | Recruiting | Shibīn al Kawm | Menoufia | 32511 | Egypt |
Data will be published after completing the study in peer reviewed journal
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 6 months |
| Clinical response | Radiological before and after the NACT (neoadjuvant chemotherapy) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 | 6months |
| Body composition changes (fat, muscles, water) | using Bioimpedance analysis (BIA) assessment 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 |