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

NCT06115486 | Recruiting

• 1 other identifier: EXERT-BCH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Carcinoma in Situ; Breast Cancer Female

Keywords

Cancer; Carcinoma in Situ; Hypertrophy; Exercise

Outcome Measures

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.

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

Secondary Outcomes (2)

• Determine adherence defined as number of sessions attended of total sessions

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

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

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

Study Arms (2)

Control Arm / ACSM Guidelines

OTHER

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 Arm / EOC Guidelines

EXPERIMENTAL

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

Control Arm ACSM Guidelines OTHER

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.

Control Arm / ACSM Guidelines

Experimental Arm 6-12-25 repetitions per set OTHER

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.

Experimental Arm / EOC Guidelines

Eligibility Criteria

• Age: 20 Years - 89 Years
• Gender Eligibility Details: Women of all races/ethnicities
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Neoplasms; Carcinoma in Situ; Hypertrophy; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Colin Champ, MD, CSCS

  Radiation Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

4123306151; clinicaltrials@ahn.org

Study Design

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

Model Details: The study will include rolling block randomization of two groups of 15 participants in each group. The 6-12-25 arm will be enrolled first, followed by the ACSM arm.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: January 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)