AzTrials
AzTrials

Breast CancerNCT07048847

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

An observational study of Breast Cancer and Colon Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Breast Cancer, Colon Cancer, Chemotherapy Effect
What is being tested?
Exercise
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2022to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Izmir, Çiğli, 35620

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Exercise
Keywords
Adiponectin, Cancer, Exercise, Irisin, IL-6, Leptin
Medical subject headings
Breast Neoplasms, Colonic Neoplasms, Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Also called Control

    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.

Study groups in NCT07048847
Study groupRoleWhat they receive
Exercise GroupPatients who will be willing to participate in supervised exercise will be grouped in Exercise Group (EG).
Receives: Other: Exercise
Control GroupPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Irisin

    Measuring Serum levels of Irisin via ELISA

    Measured: Baseline

  2. Irisin

    Measuring Serum levels of Irisin via ELISA

    Measured: From completion of systemic chemotherapy up to one week

  3. Leptin

    Measuring Serum levels of Leptin via ELISA

    Measured: Baseline

  4. Leptin

    Measuring Serum levels of Leptin via ELISA

    Measured: From completion of systemic chemotherapy up to one week

  5. Adiponectin

    Measuring Serum levels of Adiponectin via ELISA

    Measured: Baseline

  6. Adiponectin

    Measuring Serum levels of Adiponectin via ELISA

    Measured: From completion of systemic chemotherapy up to one week

  7. Interleukin-6 (IL-6)

    Measuring Serum levels of IL-6 via ELISA

    Measured: Baseline

  8. Interleukin-6 (IL-6)

    Measuring Serum levels of IL-6 via ELISA

    Measured: From completion of systemic chemotherapy up to one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start15 Sep 2022
  3. Primary completion15 Aug 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07048847
Sponsor's protocol ID
BakircayU-579/559
Status last verified
Jun 2025
First submitted
10 Jun 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data can be available with a reasonable request as well as the permission of the ethical board

Publications

  • Brownson-Smith R, Orange ST, Cresti N, Hunt K, Saxton J, Temesi J. Effect of exercise before and/or during taxane-containing chemotherapy treatment on chemotherapy-induced peripheral neuropathy symptoms in women with breast cancer: systematic review and meta-analysis. J Cancer Surviv. 2025 Feb;19(1):78-96. doi: 10.1007/s11764-023-01450-w. Epub 2023 Aug 24.

    PubMed 37615928

  • Kim JS, Galvao DA, Newton RU, Gray E, Taaffe DR. Exercise-induced myokines and their effect on prostate cancer. Nat Rev Urol. 2021 Sep;18(9):519-542. doi: 10.1038/s41585-021-00476-y. Epub 2021 Jun 22.

    PubMed 34158658

  • Tsiani E, Tsakiridis N, Kouvelioti R, Jaglanian A, Klentrou P. Current Evidence of the Role of the Myokine Irisin in Cancer. Cancers (Basel). 2021 May 27;13(11):2628. doi: 10.3390/cancers13112628.

    PubMed 34071869

  • Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Buchanan TA, Spicer DV, Tripathy D, Bernstein L, Mortimer JE. Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Mar 20;36(9):875-883. doi: 10.1200/JCO.2017.75.7526. Epub 2018 Jan 22.

    PubMed 29356607

  • Meneses-Echavez JF, Correa-Bautista JE, Gonzalez-Jimenez E, Schmidt Rio-Valle J, Elkins MR, Lobelo F, Ramirez-Velez R. The Effect of Exercise Training on Mediators of Inflammation in Breast Cancer Survivors: A Systematic Review with Meta-analysis. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1009-17. doi: 10.1158/1055-9965.EPI-15-1061. Epub 2016 Apr 12.

    PubMed 27197276

  • Tjoe JA, Piacentine LB, Papanek PE, Raff H, Richards J, Harkins AL, Yin J, Ng AV. Team triathlon effects on physiological, psychological, and immunological measures in women breast cancer survivors. Support Care Cancer. 2020 Dec;28(12):6095-6104. doi: 10.1007/s00520-020-05457-2. Epub 2020 Apr 20.

    PubMed 32314053

  • Tugral A, Aribas Z, Kaya Ucar G, Arslan FD, Bakar Y, Karakoyun I, Akyol M. The effect of supervised aerobic exercise on adipokine and myokine biomarkers in patients with cancer during systemic chemotherapy: a single-blinded prospective controlled trial. Support Care Cancer. 2025 Aug 2;33(8):741. doi: 10.1007/s00520-025-09788-w.

    PubMed 40751845

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Colon Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Irisin (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07048847, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in