The Effect of Aerobic Exercise on Selective Biomarkers of Patients With Cancer

June 24, 2025 updated by: Alper Tuğral, Izmir Bakircay University

The Effect of Supervised Aerobic Exercise on Adipokine and Myokine Biomarkers in Patients With Cancer During Systemic Chemotherapy

This study is a single-blinded, prospective, controlled trial aiming to evaluate the effect of supervised aerobic exercise on adipokine and myokine biomarkers in patients with breast or colon cancer during their systemic chemotherapy.

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

To determine the effect of aerobic exercise on adipokine and myokine biomarkers such as Interleukin-6 (IL-6), Irisin, Leptin and Adiponectin in the blood of breast or colon cancer patients receiving chemotherapy compared to ones who did not exercise during their systemic chemotherapy.

Patients who were diagnosed with solid type of cancer specifically focusing on breast or colon cancer will be recruited either to the exercise group (EG) or control group (CG) during their systemic chemotherapy. An individualized supervised resistive aerobic exercise which will be performed via stationary resistive biycle ergometer will be implemented along with the chemotherapy process for EG.

Each exercise session will be performed 2 times per week for at least 12 weeks (can be extended up to 24 weeks) during chemotherapy.

Exercise intensity will be set as submaximal, 50-70% of heart rate reserve, and each session will be lasted 35 minutes.

All exercise sessions will be supervised by the researchers to avoid potential side effects.

5 cc venous blood samples will be collected before the first and last chemotherapy infusions (for both EG and CG). The samples will be blinded to the analyzers did not know which group the samples belonged to.

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.
Observational

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.
32

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

  • Turkey
    • Çiğli
      • İzmir, Çiğli, Turkey, 35620
        • Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Having been diagnosed with solid type of cancer (specifically breast or colon) and being candidate for undergoing systemic chemotherapy.

Description

Inclusion Criteria:

  • Having been diagnosed with solid type of cancer
  • Being candidate for systemic chemotherapy
  • Being volunteer to participate in an exercise program
  • Aged between 18-70 years old

Exclusion Criteria:

  • Having 2 or above grades according to the Eastern Cooperative Oncology Group (ECOG) performance status
  • Having mental and/or cognitive deficits
  • Ongoing medical and/or surgical (if any) complications
  • Having neurological/orthopedical and/or severe respiratory dysfunctions
  • Having any condition which corresponds to the contraindication of exercise (i.e. advanced stages, distant metastasis, infection)
  • Having unstable vital parameters or having regularly used pharmacological interventions

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Exercise Group
Patients who will be willing to participate in supervised exercise will be grouped in Exercise Group (EG).
Other: Exercise
The exercise program will be started with 25 Watt (W) for 5 minutes of warm-up. Then it is steadily increased automatically by 5W in 5 minutes apart for 25 minutes for the loading period. The last 5 minutes which will be started by lowering the load to 25 W for cooling will be implemented for cooling down. To prevent acommodation, the warm-up period will be modified by increasing nearly 10% of its previous rate three weeks apart.A submaximal exercise prescription will be followed according to the American College of Sports Medicine guideline by taking into attention 50-70% of Heart Rate Reserve.A submaximal exercise prescription will be followed according to the American College of Sports Medicine guideline by taking into attention 50-70% of Heart Rate Reserve.
Other Names:
  • Control
Control Group
Patients who are not willing to participate in exercise due to various reasons (time restrictions, other obligations, transport, etc.) will be grouped in the Control Group (CG).

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
Irisin
Time Frame: Baseline
Measuring Serum levels of Irisin via ELISA
Baseline
Irisin
Time Frame: From completion of systemic chemotherapy up to one week
Measuring Serum levels of Irisin via ELISA
From completion of systemic chemotherapy up to one week
Leptin
Time Frame: Baseline
Measuring Serum levels of Leptin via ELISA
Baseline
Leptin
Time Frame: From completion of systemic chemotherapy up to one week
Measuring Serum levels of Leptin via ELISA
From completion of systemic chemotherapy up to one week
Adiponectin
Time Frame: Baseline
Measuring Serum levels of Adiponectin via ELISA
Baseline
Adiponectin
Time Frame: From completion of systemic chemotherapy up to one week
Measuring Serum levels of Adiponectin via ELISA
From completion of systemic chemotherapy up to one week
Interleukin-6 (IL-6)
Time Frame: Baseline
Measuring Serum levels of IL-6 via ELISA
Baseline
Interleukin-6 (IL-6)
Time Frame: From completion of systemic chemotherapy up to one week
Measuring Serum levels of IL-6 via ELISA
From completion of systemic chemotherapy up to one week

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.
Izmir Bakircay University

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: Alper Tuğral, PhD, Izmir Bakircay University

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.
September 15, 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.
August 15, 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.
December 1, 2023

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).
June 10, 2025

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.
June 24, 2025

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.
July 3, 2025

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.
July 3, 2025

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.
June 24, 2025

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.
June 1, 2025

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.
  • BakircayU-579/559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data can be available with a reasonable request as well as the permission of the ethical board

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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