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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

Izmir Bakircay University

Investigators

  • 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)

September 15, 2022

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

June 24, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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