Breast Cancer, Breast Cancer Female, Breast Carcinoma in Situ
Conditions
Keywords
Cancer, Carcinoma in Situ, Hypertrophy, Exercise
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.
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).
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.
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 89 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine changes in muscle and fat mass during and after each exercise regimen | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension. |
| 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. | The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension. |
Countries
United States
Contacts
CONTACTClinical Trials Contact
PRINCIPAL_INVESTIGATORColin Champ, MD, CSCS
Radiation Oncologist
Outcome results
None listed