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Sponsor: Khyber Medical University Peshawar
Conditions: Breast Cancer
Interventions: Conventional Chemotherapy, Intermittent Fasting (23:1 Regimen), Ketogenic Diet, Water-Only Fasting
Countries: Pakistan
This randomized controlled trial investigates the effects of intermittent fasting and water-only fasting on gene expression, tumor markers, quality of life, and chemotherapy tolerance in breast cancer patients receiving chemotherapy. Breast cancer remains the most commonly diagnosed cancer worldwide, and while chemotherapy constitutes standard treatment, it is frequently accompanied by significant adverse effects including cachexia and immunosuppression. Fasting has emerged as a promising complementary approach that may enhance chemotherapy efficacy while protecting healthy cells from treatment-related toxicity. The study will enroll 60 female breast cancer patients from INOR, Abbottabad, who will be randomly assigned to one of four groups: conventional chemotherapy alone, chemotherapy combined with intermittent fasting (23:1 hour fasting to eating ratio) plus routine diet, chemotherapy combined with intermittent fasting plus ketogenic diet, or chemotherapy combined with water-only fasting for two weeks. Blood samples will be collected before and after interventions to assess tumor marker CA 15-3, CD4+ and CD8+ T cell counts, oxidative stress marker malondialdehyde, inflammatory markers including TNF-α and neutrophil-lymphocyte ratio, Glasgow Prognostic Score, and metabolic regulators AMPK and pyruvate dehydrogenase. Quality of life will be evaluated using the validated FACT-B questionnaire, while chemotherapy tolerance will be assessed through symptom severity surveys. The study hypothesizes that combining fasting regimens with standard chemotherapy will enhance anti-tumor effects, improve immune surveillance mechanisms, and ultimately contribute to better prognostic outcomes in breast cancer patients.
Sex: FEMALE
Age: 18 Years to 50 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Female patients aged 18 to 50 years * Histologically confirmed breast cancer (any TNM stage) * Currently receiving chemotherapy treatment at INOR, Abbottabad * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Body mass index (BMI) ≥ 24 kg/m² * Willing and able to provide written informed consent * Willing to comply with the assigned fasting and dietary interventions Exclusion Criteria: * Distant metastasis to liver or kidneys * ECOG performance status of 3 or 4 * Uncontrolled systemic diseases including cardiovascular disease, lung disease, or clinically confirmed metabolic disease * Human immunodeficiency virus (HIV) infection, chronic hepatitis B, hepatitis C, or other active infections clinically confirmed * Pregnant or lactating women * Concurrent participation in another interventional clinical trial * Inability to comply with fasting protocols due to medical or psychological reasons * Known contraindications to fasting including but not limited to eating disorders, severe malnutrition, or uncontrolled diabetes mellitus * Use of medications that may interfere with fasting or ketogenic diet (e.g., insulin, oral hypoglycemic agents requiring food intake) * Any condition that in the opinion of the investigator would compromise the safety of the participant or the integrity of the study
- Abbottābād, Khyber Pakhtunkhwa, Pakistan