Impact Of Intermittent And Water-Only Fasting On Gene Expression And Tumor Markers In Breast Cancer

Summary

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.

Conditions

• Breast Cancer

Interventions

DRUG

Conventional Chemotherapy

Participants receive standard chemotherapy treatment according to institutional protocols at INOR. The specific chemotherapy regimen, dosage, frequency, and duration are determined by the treating oncologist based on the patient's histological

BEHAVIORAL

Intermittent Fasting (23:1 Regimen)

Participants undergo an intermittent fasting regimen consisting of 23 consecutive hours of fasting followed by a 1-hour eating period daily for 30 days. During the fasting period, participants consume no food or calorie-containing beverages; only water and zero-calorie drinks (plain water, zero-calorie herbal tea, black coffee without sugar) are permitted. During the 1-hour eating window, participants consume one meal. This regimen is implemented alongside standard chemotherapy.

DIETARY_SUPPLEMENT

Ketogenic Diet

Participants follow a ketogenic diet during their 1-hour eating window as part of the intermittent fasting regimen. The diet consists of high fat content (approximately 75% of calories from fat), moderate to low protein (approximately 20% of calories), and very low carbohydrates (approximately 5% of calories). Participants receive comprehensive dietary resources including ketogenic food lists (meat, fish, eggs, nuts, high-fat dairy, above-ground vegetables, berries, and natural fats such as coconut oil and olive oil), daily meal plans, and lists of prohibited high-carbohydrate foods. This dietary intervention aims to induce and maintain nutritional ketosis throughout the 30-day study period.

BEHAVIORAL

Water-Only Fasting

Participants undergo a water-only fasting regimen for 14 consecutive days. During this period, participants consume only water, zero-calorie herbal tea, or black coffee without sugar or milk. No food or calorie-containing beverages are permitted. Limited physical exertion is advised. Following completion of the 14-day fast, participants undergo a structured gradual refeeding protocol: initial introduction of fruit juices and vegetable broths, followed by raw fruits and steamed vegetables, and progressively transitioning back to a normal diet. This intervention is administered alongside standard chemotherapy.

Sponsors & Collaborators

• Khyber Medical University Peshawar

  lead OTHER

Principal Investigators

• Yasmeen Bibi, PhD Scholar · Khyber Medical University Peshawar

• Muhammad Omar Malik, PhD · Khyber Medical University Peshawar, Pakistan

• Sajid Zaman, PhD · Head of Oncology Department, INOR, Abbottabad, Pakistan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2023-07-31

Completion

2026-03-30

Countries

• Pakistan