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RecruitingNCT06115486Updated Feb 4, 2026

EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer

An interventional study of Control Arm ACSM Guidelines and Experimental Arm 6-12-25 repetitions per set in Breast Cancer, Breast Carcinoma in Situ and Breast Cancer Female, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 1 site in United States. Open to female participants aged 20 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 89 Years
Sex
Female
01

Study summary

The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

Read the detailed description

This protocol seeks to analyze patient outcomes of two standard of care, time-efficient, monitored group exercise regimens of high-load resistance training to improve hypertrophy in women who have been treated for ductal carcinoma in situ or invasive carcinoma of the breast.

As part of the standard exercise program, patients will undergo a fitness evaluation at the AHNCI Exercise Oncology and Resiliency Center before the start of the exercise program. This evaluation will be used to customize the patient exercise program. The exercise program consists of small group training sessions held approximately 3 times per week at the center for 12 weeks (3 months). The fitness evaluation and exercise program are standard of care. Participation in this study will last the duration of the exercise program, about 3 months. All group exercise sessions will be closely monitored by the center staff who are Certified Strength and Conditioning Specialists (CSCS).

02

Conditions studied

  • Breast Cancer
  • Breast Carcinoma in Situ
  • Breast Cancer Female

Keywords

  • Cancer
  • Carcinoma in Situ
  • Hypertrophy
  • Exercise
03

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

Age 20-89 years

  • Women with a biopsy proven diagnosis of ductal carcinoma in situ 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.

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Control Arm / ACSM Guidelines

    The control group will follow resistance training guidelines from the American College of Sports Medicine (ACSM) with the goal of promoting hypertrophy

    Other: Control Arm ACSM Guidelines

  • Experimental
    Experimental Arm / EOC Guidelines

    The experimental group will use a regimen that is often used by strength and conditioning coaches to maximize hypertrophy, and is part of the standard regimens at the Exercise Oncology Center (EOC)

    Other: Experimental Arm 6-12-25 repetitions per set

Interventions

  • OtherControl Arm ACSM Guidelines

    The control group will follow resistance training guidelines from the American College of Sports Medicine. Eight to ten multi-joint exercises will be performed to stress the major muscle groups.

  • OtherExperimental Arm 6-12-25 repetitions per set

    The exercise regimens will employ a mixture of compound exercises utilizing both open and closed kinetic chain movements (CKC), focusing on exercises with the goal of increasing skeletal muscle mass and body composition. The regimen will incorporate 6, then 12, then 25 repetitions in sequence per set per muscle group with minimal amounts of rest between.

05

What researchers measure

Primary outcomes

  1. Determine changes in muscle and fat mass during and after each exercise regimen

    The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.

    Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.

Secondary outcomes

  1. Determine adherence defined as number of sessions attended of total sessions

    The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.

    Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.

  2. Determine changes in strength measured via load calculations (repetitions x sets x weight)

    The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.

    Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.

06

Study locations

1 of 1 sites recruiting
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — No plan to share data

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06115486
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Responsible party
Colin Champ, MD (Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)) — Principal investigator
First posted
Nov 3, 2023
Start date
Jan 9, 2024
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Feb 4, 2026

Study contacts

Clinical Trials Contact
Contact
clinicaltrials@ahn.org
4123306151
Colin Champ, MD, CSCS
principal investigator · Radiation Oncologist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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