Effects of intermittent fasting on breast cancer treatment
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
This study tests if intermittent fasting can help women with locally advanced breast cancer respond better to chemotherapy while keeping their healthy cells safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Menoufia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shibīn Al Kawm, Menoufia) |
| Trial ID | NCT06174259 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of intermittent fasting on women with locally advanced breast cancer who are undergoing neoadjuvant chemotherapy. It aims to determine whether fasting can enhance the effectiveness of chemotherapy by making cancer cells more vulnerable while protecting normal cells. The study focuses on female patients with stage II or III breast cancer who are overweight or obese and have measurable disease. Participants will be monitored for their response to treatment and overall health during the fasting regimen.
Who should consider this trial
Good fit: Ideal candidates are female patients with stage II or III breast cancer who are overweight or obese and scheduled to receive neoadjuvant chemotherapy.
Not a fit: Patients with serious comorbidities, diabetes, or metabolic disorders that affect fasting may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While intermittent fasting has shown promise in preclinical studies, this specific approach in breast cancer treatment is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shibīn Al Kawm, Menoufia
- Menoufia university — Shibīn Al Kawm, Menoufia, Egypt (Recruiting)
Study contacts
- Study coordinator: Yostena Mekhail, MD
- Email: youstena.kamel@med.menofia.edu.eg
- Phone: 800-545-5557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.