Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

Launched by MENOUFIA UNIVERSITY · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of intermittent fasting on women with locally advanced breast cancer who are about to start a specific type of chemotherapy called neoadjuvant chemotherapy. Researchers want to see if fasting can help make the chemotherapy more effective by protecting healthy cells while making cancer cells more vulnerable. This is important because breast cancer is the most common cancer among women, and finding new ways to enhance treatment could lead to better outcomes.

To be eligible for the trial, participants need to be female, between the ages of 65 to 74, and diagnosed with stage II or III breast cancer. They should also be overweight or obese, have measurable cancer, and meet certain health criteria, such as having good blood cell counts and organ function. Participants in the trial can expect to follow a fasting schedule while receiving their chemotherapy treatment, and they will be monitored closely by the research team throughout the study. It’s also important to note that those with serious health issues, diabetes, or who are pregnant cannot participate in this trial.

Gender

FEMALE

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.