NCT07048847

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 10, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

AdiponectinCancerExerciseIrisinIL-6Leptin

Outcome Measures

Primary Outcomes (8)

  • Irisin

    Measuring Serum levels of Irisin via ELISA

    Baseline

  • Irisin

    Measuring Serum levels of Irisin via ELISA

    From completion of systemic chemotherapy up to one week

  • Leptin

    Measuring Serum levels of Leptin via ELISA

    Baseline

  • Leptin

    Measuring Serum levels of Leptin via ELISA

    From completion of systemic chemotherapy up to one week

  • Adiponectin

    Measuring Serum levels of Adiponectin via ELISA

    Baseline

  • Adiponectin

    Measuring Serum levels of Adiponectin via ELISA

    From completion of systemic chemotherapy up to one week

  • Interleukin-6 (IL-6)

    Measuring Serum levels of IL-6 via ELISA

    Baseline

  • Interleukin-6 (IL-6)

    Measuring Serum levels of IL-6 via ELISA

    From completion of systemic chemotherapy up to one week

Study Arms (2)

Exercise Group

Patients who will be willing to participate in supervised exercise will be grouped in Exercise Group (EG).

Other: Exercise

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).

Interventions

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.

Also known as: Control
Exercise Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Izmir, Çiğli, 35620, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 37615928BACKGROUND
  • 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.

    PMID: 34158658BACKGROUND
  • 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.

    PMID: 34071869BACKGROUND
  • 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.

    PMID: 29356607BACKGROUND
  • 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.

    PMID: 27197276BACKGROUND
  • 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.

    PMID: 32314053BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

For both EG and CG, two blood samplings were performed for each patient. 5 cc venous blood was collected from all the participants and centrifuged at 1500 g for 10 minutes. Separated serum was stored at -20 °C until analysis. Serum leptin, IL-6, irisin, and adiponectin concentrations were measured by using enzyme-linked immunosorbent assay (ELISA) method.

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsNeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alper Tuğral, PhD

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Coordinator

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 3, 2025

Study Start

September 15, 2022

Primary Completion

August 15, 2023

Study Completion

December 1, 2023

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations