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Trial Title:
EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer
NCT ID:
NCT06115486
Condition:
Breast Cancer
Breast Carcinoma in Situ
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Carcinoma in Situ
Breast Carcinoma In Situ
Conditions: Keywords:
Cancer
Carcinoma in Situ
Hypertrophy
Exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Control Arm ACSM Guidelines
Description:
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.
Arm group label:
Control Arm / ACSM Guidelines
Intervention type:
Other
Intervention name:
Experimental Arm 6-12-25 repetitions per set
Description:
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.
Arm group label:
Experimental Arm / EOC Guidelines
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.
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).
Criteria for eligibility:
Criteria:
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:
- 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
Gender:
Female
Gender based:
Yes
Gender description:
Women of all races/ethnicities
Minimum age:
20 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Contact
Email:
clinicaltrials@ahn.org
Start date:
January 9, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Agency class:
Other
Source:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06115486
