A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer (Myo-EXERTBC)

Myo-EXERTBC: A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer

In this pilot study, the investigators will assess the changes in myokine production based on several different exercise regimens.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • 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 Contact

  • Name: Clinical Trials Contact
  • Phone Number: 412-330-6151
  • Email: ctgov@ahn.org

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • AHN Allegheny General Hospital
        • Contact:

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

Description

Inclusion Criteria:

  1. Age 20-89 years
  2. Women prescribed exercise as a SOC
  3. Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
  4. Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
  5. Women with > 3 months of resistance training experience under expert guidance at the Allegheny Health Network Exercise Oncology Center

Exclusion Criteria:

  1. Any current treatment with cytotoxic chemotherapy for breast cancer
  2. Inability to safely engage in group sessions of resistance training as deemed by study PI
  3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
  4. Pregnant women
  5. Males

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conditioning Regimen Group
Participants in this group will perform a conditioning regimen from the EXERT-BCHC protocol, specifically described as "double training".
Experimental: Strength Regimen Group
Participants in this group will perform a strength regimen from the EXERT-BCHC protocol, specifically described as "8x8".
Experimental: Hypertrophy Regimen Group
Participants in this group will perform a hypertrophy regimen from the EXERT-BCHC protocol, specifically described as the "control arm".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Myokine Production After First Exercise Session
Time Frame: Immediately before and immediately after the first exercise session.
Quantification of a panel of 15 myokines (IL-5, IL-1ra, LIF, Irisin, SPARC, Decorin, Oncostatin M, Myostatin, Follistatin, Apelin, Fibroblast Growth Factor 21 (FGF21), Cathepsin-B, IL-15, METRNL, Myonectin) in both serum and tear samples. The change from pre-exercise to post-exercise levels will be determined.
Immediately before and immediately after the first exercise session.
Change in Myokine Production After Final Exercise Session of Each Week
Time Frame: Immediately before and immediately after the final exercise session of weeks 1, 2, 3, and 4.
Quantification of a panel of 15 myokines (IL-5, IL-1ra, LIF, Irisin, SPARC, Decorin, Oncostatin M, Myostatin, Follistatin, Apelin, Fibroblast Growth Factor 21 (FGF21), Cathepsin-B, IL-15, METRNL, Myonectin) in both serum and tear samples for each group. The change from pre-exercise to post-exercise levels at the end of each week will be determined.
Immediately before and immediately after the final exercise session of weeks 1, 2, 3, and 4.
Change in Myokine Production After Final Exercise Session of the Month (End of Study)
Time Frame: Immediately before and immediately after the final exercise session of week 4 (end of the 4-week exercise regimen).
Quantification of a panel of 15 myokines (IL-5, IL-1ra, LIF, Irisin, SPARC, Decorin, Oncostatin M, Myostatin, Follistatin, Apelin, Fibroblast Growth Factor 21 (FGF21), Cathepsin-B, IL-15, METRNL, Myonectin) in both serum and tear samples for each group. The change from pre-exercise to post-exercise levels at the culmination of the 4-week exercise period will be determined.
Immediately before and immediately after the final exercise session of week 4 (end of the 4-week exercise regimen).

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Colin Champ, MD, AHN Radiation Oncology

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

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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