Breast CancerNCT06115486
EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer
A study testing Experimental Arm 6-12-25 repetitions per set in people with Breast Cancer and Breast Carcinoma in Situ, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 89 years, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma in Situ, Breast Cancer Female
- What is being tested?
- Experimental Arm 6-12-25 repetitions per set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, clinicaltrials@ahn.org
About this study
Official title: EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy
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).
- Being tested
- Control Arm ACSM Guidelines, Experimental Arm 6-12-25 repetitions per set
- Keywords
- Cancer, Carcinoma in Situ, Hypertrophy, Exercise
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Neoplasms, Carcinoma in Situ, Hypertrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Arm ACSM GuidelinesOther
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.
Experimental Arm 6-12-25 repetitions per setOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: Experimental Arm 6-12-25 repetitions per set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.
Measured: 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 experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.
Measured: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start9 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Colin Champ, MD, CSCS, Principal investigator, Radiation Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115486
- Sponsor's protocol ID
- EXERT-BCH
- Status last verified
- Feb 2026
- First submitted
- 30 Oct 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy
- ClinicalTrials.gov ID
- NCT06115486
- Acronym / sponsor ID
- EXERT-BCH
- Keywords
- Cancer, Carcinoma in Situ, Hypertrophy, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Arm / ACSM Guidelines | Other | Other: Control Arm ACSM GuidelinesThe control group will follow resistance training guidelines from the American College of Sports Medicine (ACSM) with the goal of promoting hypertrophy |
| Experimental Arm / EOC Guidelines | Experimental | Other: Experimental Arm 6-12-25 repetitions per setThe 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) |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Arm ACSM GuidelinesThe 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. | Other | Control Arm / ACSM Guidelines |
| Experimental Arm 6-12-25 repetitions per setThe 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. | Other | Experimental Arm / EOC Guidelines |
Primary outcome
Determine changes in muscle and fat mass during and after each exercise regimen
Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.
2 secondary outcomes
Determine adherence defined as number of sessions attended of total sessions
Time frame: 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)
Time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. No plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Champ, MD, CSCS principal investigator
Radiation Oncologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Arm 6-12-25 repetitions per set in people with Breast Cancer and Breast Carcinoma in Situ, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Contact (4123306151, clinicaltrials@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine changes in muscle and fat mass during and after each exercise regimen (time frame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.