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

Plain-language summary

This study examines the effect of nutritional approaches such as intermittent fasting, water-only fasting, and a ketogenic diet on gene expression and tumor markers in patients with breast cancer who are receiving chemotherapy. Female patients aged 18-50 with a histologically confirmed breast cancer diagnosis who are currently on chemotherapy can take part. It is a study with no assigned phase and is active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

Khyber Medical University Peshawar

Intervention

Conventional Chemotherapy, Intermittent Fasting (23:1 Regimen), Ketogenic Diet, Water-Only Fasting

Start date

8/1/2022

Estimated completion

3/30/2026

Countries

Pakistan

Related genes

Locations

• Abbottābād, Pakistan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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