Clinical trial · Interventional
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intermittent Fasting | — | UNRESOLVED | — |
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intermittent fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intermittent fasting
- description
- 16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy.
- interventionNames
- Other: intermittent fasting
- type
- NO_INTERVENTION
- label
- regular diet
- description
- Regular diet around standard neoadjuvant chemotherapy
Primary outcomes (1)
- measure
- pathological response rate
- timeFrame
- 6months
- description
- Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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