NCT07698314

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable cancer

Timeline
22mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress8%
Jun 2026Jun 2028

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Myokine Production After 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

    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)

    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).

Study Arms (3)

Conditioning Regimen Group

EXPERIMENTAL
Behavioral: Conditioning Resistance Training

Strength Regimen Group

EXPERIMENTAL
Behavioral: Strength Resistance Training

Hypertrophy Regimen Group

EXPERIMENTAL
Behavioral: Hypertrophy Resistance Training

Interventions

Participants in this group will perform a conditioning regimen from the EXERT-BCHC protocol, specifically described as "double training".

Conditioning Regimen Group

Participants in this group will perform a strength regimen from the EXERT-BCHC protocol, specifically described as "8x8".

Strength Regimen Group

Participants in this group will perform a hypertrophy regimen from the EXERT-BCHC protocol, specifically described as the "control arm".

Hypertrophy Regimen Group

Eligibility Criteria

Age20 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-89 years
  • Women prescribed exercise as a SOC
  • Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
  • 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.
  • Women with \> 3 months of resistance training experience under expert guidance at the Allegheny Health Network Exercise Oncology Center

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

NeoplasmsBreast Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Colin Champ, MD

    AHN Radiation Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations