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

August 16, 2026 updated by: Khyber Medical University Peshawar
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective randomized controlled intervention trial is designed to comprehensively evaluate the molecular, immunological, and clinical effects of intermittent and water-only fasting in breast cancer patients undergoing chemotherapy, and will be conducted at the Institute of Nuclear Medicine Oncology and Radiotherapy in Abbottabad in collaboration with the Institute of Basic Medical Sciences, Khyber Medical University, Peshawar. The scientific rationale underlying this investigation stems from the understanding that cancer functions as a metabolic disease characterized by dysfunctional mitochondria and reliance on aerobic glycolysis for energy production, as described by the Warburg hypothesis. By restricting glucose availability through fasting regimens, cancer cells may be selectively starved while normal cells undergo metabolic adaptation, potentially enhancing chemotherapy sensitivity and reducing treatment-related toxicity. Furthermore, fasting has demonstrated immunomodulatory properties through increasing cytotoxic CD8+ T cell precursors and enhancing immune response, while triggering autophagy and inducing differential stress resistance that sensitizes cancer cells to chemotherapy. The study objectives include assessing the effects of intermittent fasting and water-only fasting on quality of life, chemotherapy tolerance, gene expression patterns, and tumor biomarkers, as well as comparing the relative efficacy of these two fasting approaches in improving clinical outcomes. The four study groups will each comprise 15 participants, with group 1 receiving conventional chemotherapy only as the control arm, group 2 undergoing 30 days of intermittent fasting with one routine meal daily, group 3 following 30 days of intermittent fasting with one ketogenic meal daily accompanied by comprehensive dietary guidance and food lists, and group 4 completing a 14-day water-only fast allowing only water, zero-calorie herbal tea, or black coffee without sugar followed by gradual refeeding with juices, broths, and progressive introduction of solid foods. Blood sampling of approximately 10 milliliters will be performed at baseline and following completion of the respective interventions, with serum analyzed for malondialdehyde levels using the thiobarbituric acid method, CD4 and CD8 T cell enumeration through flow cytometry, and quantification of pyruvate dehydrogenase, tumor necrosis factor-alpha, AMPK, albumin, and C-reactive protein using commercially available ELISA kits, while ketone bodies will be measured using a ketone meter. Statistical analysis will be performed using SPSS version 20 with data presented as mean values plus or minus standard error of the mean, analysis of variance applied to identify differences among groups followed by Tukey post-hoc tests, and Pearson correlation coefficients calculated to examine relationships between variables, with statistical significance established at p-values less than 0.05. Ethical approval has been obtained from the Ethics Committee of INOR Abbottabad, and all participants will provide written informed consent after receiving comprehensive information about study procedures, potential benefits, and possible risks including dizziness, weakness, or difficulty tolerating dietary interventions, with assurance of their right to withdraw at any time without providing explanation and without affecting their medical care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Abbottābād, Khyber Pakhtunkhwa, Pakistan, 22010
        • Institute of Nuclear Medicine Oncology & Radiotherapy (INOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Chemotherapy (Control Group)
Participants receive conventional chemotherapy treatment according to standard protocols at INOR, Abbottabad, with no dietary restrictions or fasting interventions. Patients consume their routine diet throughout the 4-week study period. Blood samples are collected at baseline and after 4 weeks for biomarker analysis. This group serves as the control arm against which the three fasting intervention groups will be compared.
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
Experimental: Intermittent Fasting + Routine Diet
Participants receive standard chemotherapy alongside an intermittent fasting regimen consisting of 23 hours of fasting with a 1-hour eating period daily for 30 consecutive days. During the 1-hour eating window, participants consume one routine meal per day consisting of their usual diet without specific dietary modifications. No food or calorie-containing beverages are consumed during the 23-hour fasting period; only water and zero-calorie drinks are permitted. Blood samples are collected at baseline and after completion of the 30-day intervention period. This arm evaluates the effects of intermittent fasting alone without dietary composition changes.
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.
Experimental: Intermittent Fasting + Ketogenic Diet
Participants receive standard chemotherapy combined with an intermittent fasting regimen of 23 hours fasting and 1-hour eating daily for 30 consecutive days. During the 1-hour eating window, participants consume one classic ketogenic meal following provided dietary guidelines. The ketogenic diet comprises high fat content (approximately 75-90% of calories), moderate to low protein, and very low carbohydrates (approximately 5% of calories) to induce and maintain nutritional ketosis. Participants receive comprehensive resources including ketogenic food lists, daily meal plans, and lists of prohibited foods. Only water and zero-calorie beverages are permitted during fasting periods. Blood samples are collected at baseline and post-intervention to assess biomarkers including ketone bodies. This arm evaluates the combined effects of intermittent fasting and ketogenic diet on study outcomes.
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.
Experimental: Water-Only Fasting
Participants receive standard chemotherapy combined with 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. Limited physical exertion is permitted. After completing the 14-day water-only fast, participants undergo a gradual refeeding protocol beginning with fruit juices and vegetable broths, followed by raw fruits and steamed vegetables, and progressively transitioning back to a normal diet. Blood samples are collected at baseline and after completion of the 14-day fasting period. This arm evaluates the effects of short-term prolonged water-only fasting on tumor markers, immune function, and chemotherapy tolerance in breast cancer patients.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Serum Cancer Antigen 15-3 (CA 15-3) Levels
Time Frame: Baseline (prior to intervention initiation) and immediately following completion of the assigned fasting intervention: at 4 weeks for Groups 1, 2, and 3; at 2 weeks for Group 4 (Water-Only Fasting)
CA 15-3 is a protein secreted primarily by breast cancer cells and serves as a clinically validated tumor marker for monitoring treatment response and disease progression in breast cancer patients. Blood samples will be collected via venipuncture, and serum CA 15-3 concentrations will be quantified using commercially available ELISA kits according to manufacturer instructions. Measurements will be performed at baseline prior to any intervention and repeated following completion of the assigned fasting protocol. The change in CA 15-3 levels (post-intervention value minus baseline value) will be calculated and compared across the four study groups to evaluate the effect of intermittent fasting, ketogenic diet combined with intermittent fasting, and water-only fasting on this tumor marker relative to conventional chemotherapy alone.
Baseline (prior to intervention initiation) and immediately following completion of the assigned fasting intervention: at 4 weeks for Groups 1, 2, and 3; at 2 weeks for Group 4 (Water-Only Fasting)
Change in CD4+ and CD8+ T Cell Counts
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
CD4+ helper T cells and CD8+ cytotoxic T cells are essential components of adaptive immunity and play critical roles in anti-tumor immune responses. Venous blood samples will be collected at baseline and post-intervention. CD4+ and CD8+ T cell counts will be enumerated using flow cytometry with the FlowCellct Human CD4/CD8 T Cell Kit (MERCK) according to manufacturer protocols. Absolute counts and CD4/CD8 ratios will be determined. Changes in these immune cell populations will be compared across groups to assess whether fasting regimens enhance cellular immunity in breast cancer patients undergoing chemotherapy.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Serum Malondialdehyde (MDA) Levels
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Malondialdehyde is a reactive aldehyde and end product of lipid peroxidation, serving as a reliable biomarker of oxidative stress. Elevated MDA levels have been documented in breast cancer patients and correlate with disease progression. Serum MDA concentrations will be determined using the thiobarbituric acid (TBA) method spectrophotometrically. Baseline and post-intervention values will be compared to evaluate whether fasting interventions reduce oxidative stress burden in patients receiving chemotherapy.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Neutrophil-Lymphocyte Ratio (NLR)
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
The neutrophil-lymphocyte ratio is a systemic inflammatory marker calculated by dividing absolute neutrophil count by absolute lymphocyte count from complete blood count analysis. Elevated NLR has been associated with poor prognosis in various cancers, including breast cancer. NLR will be calculated from routine complete blood count performed at baseline and post-intervention. Changes in NLR will be analyzed to determine whether fasting regimens modulate systemic inflammation in the context of chemotherapy.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Levels
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
TNF-α is a pro-inflammatory cytokine involved in systemic inflammation and has been implicated in tumor growth, metastasis, and cancer-related cachexia. Elevated TNF-α levels correlate with advanced disease stage in breast cancer. Serum TNF-α concentrations will be measured using commercially available ELISA kits. Baseline and post-intervention values will be compared across study groups to assess the anti-inflammatory effects of fasting interventions.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Glasgow Prognostic Score (GPS)
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
The Glasgow Prognostic Score is an inflammation-based prognostic score calculated from serum C-reactive protein (CRP) and albumin levels. The modified GPS used in this study assigns scores as follows: 0 for CRP ≤ 1.0 mg/dl; 1 for CRP > 1.0 mg/dl and albumin ≥ 3.5 mg/dl; 2 for CRP > 1.0 mg/dl and albumin < 3.5 mg/dl. CRP will be measured by immunoassay and albumin by standard laboratory methods. Changes in GPS will be compared to evaluate whether fasting improves the inflammatory and nutritional status of breast cancer patients.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Serum AMP-Activated Protein Kinase (AMPK) Levels
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
AMPK is a cellular energy sensor activated during glucose shortage and conditions of metabolic stress. Activated AMPK promotes catabolic pathways including autophagy and fatty acid oxidation while inhibiting anabolic processes. Fasting is known to activate AMPK, which may contribute to its anti-tumor effects. Serum AMPK levels will be quantified using ELISA kits. Baseline and post-intervention values will be compared to assess the molecular impact of fasting regimens on cellular energy sensing pathways.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Serum Pyruvate Dehydrogenase (PDH) Levels
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Pyruvate dehydrogenase is a mitochondrial enzyme that catalyzes the irreversible conversion of pyruvate to acetyl-CoA, linking glycolysis to the tricarboxylic acid cycle. PDH activity serves as a marker of aerobic metabolism and is often dysregulated in cancer cells exhibiting the Warburg effect. Serum PDH levels will be measured using ELISA kits. Changes in PDH will be evaluated to determine whether fasting interventions promote metabolic reprogramming away from aerobic glycolysis toward oxidative phosphorylation.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Quality of Life Assessed by FACT-B Scale
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Quality of life will be assessed using the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) questionnaire, a validated 37-item instrument consisting of the general FACT-G scale and a breast cancer subscale (BCS). The questionnaire evaluates five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns. Each item is scored from 0 to 4, with higher scores indicating better quality of life. Total scores range from 0 to 148. The questionnaire will be administered at baseline and post-intervention to evaluate whether fasting interventions impact patient-reported quality of life during chemotherapy.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Chemotherapy Tolerance Assessed by Symptom Severity Survey
Time Frame: Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Chemotherapy tolerance will be evaluated using a symptom severity survey adapted from published fasting and cancer treatment studies. The survey assesses common chemotherapy-related symptoms including fatigue, nausea, vomiting, appetite changes, taste alterations, dry mouth, constipation, diarrhea, mucositis, peripheral neuropathy (numbness, tingling), cognitive impairment, and pain. Each symptom is scored from 0 (absent) to 4 (severe/maximum). The survey will be administered at baseline and post-intervention to determine whether fasting interventions reduce the severity of chemotherapy-induced adverse effects.
Baseline and post-intervention (4 weeks for Groups 1-3; 2 weeks for Group 4)
Change in Blood Ketone Body Levels
Time Frame: Baseline and during intervention: weekly for Groups 2-3 (30 days); days 3, 7, and 14 for Group 4
Ketone bodies (primarily beta-hydroxybutyrate) are produced during fasting and ketogenic diet interventions and may mediate anti-tumor effects through metabolic and signaling mechanisms. Blood ketone levels will be measured using a ketone meter with test strips at baseline and at regular intervals during the intervention period. For Groups 2 and 3, measurements will be taken weekly during the 30-day intervention. For Group 4, measurements will be taken at days 3, 7, and 14 of the water-only fast. Ketone levels will be correlated with other outcome measures to explore the relationship between nutritional ketosis and therapeutic effects.
Baseline and during intervention: weekly for Groups 2-3 (30 days); days 3, 7, and 14 for Group 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Khyber Medical University Peshawar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yasmeen Bibi, PhD Scholar, Khyber Medical University Peshawar
  • Principal Investigator: Muhammad Omar Malik, PhD, Khyber Medical University Peshawar, Pakistan
  • Principal Investigator: Sajid Zaman, PhD, Head of Oncology Department, INOR, Abbottabad, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMU/DIR/CTU/2025/015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data collected during this trial, including de-identified demographic information, clinical characteristics, laboratory biomarker results (CA 15-3, CD4/CD8 counts, MDA, TNF-α, NLR, GPS, AMPK, PDH), quality of life questionnaire responses (FACT-B), and chemotherapy tolerance survey data, will be made available to other researchers upon reasonable request. The data will be shared after de-identification to protect participant privacy. The study protocol, statistical analysis plan, and analytic code will be included to enable reproducibility and secondary analyses.

IPD Sharing Time Frame

Individual participant data will become available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years. Data requests will be considered during this timeframe.

IPD Sharing Access Criteria

Data will be made available to qualified researchers affiliated with academic institutions or research organizations who submit a methodologically sound research proposal. Requests must include a clear description of the proposed analyses, institutional ethics approval or documented exemption, and a signed data sharing agreement that includes: (1) a commitment to use data only for approved research purposes, (2) assurance of no attempts to re-identify participants, (3) agreement to maintain data security, and (4) commitment to acknowledge the original study in any resulting publications. Proposals should be submitted to the Principal Investigator (Dr. Yasmeen Bibi) or the Supervising Investigator (Dr. Muhammad Omar Malik) for review and approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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