Clinical trial NCT06115486: EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer
Official title: EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Carcinoma in Situ
Breast Cancer Female
Keywords: Cancer
Carcinoma in Situ
Hypertrophy
Exercise
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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).

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

Primary outcomes:
measure: Determine changes in muscle and fat mass during and after each exercise regimen
timeFrame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
Secondary outcomes:
measure: Determine adherence defined as number of sessions attended of total sessions
timeFrame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
measure: Determine changes in strength measured via load calculations (repetitions x sets x weight)
timeFrame: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Radiation Oncologist
name: Colin Champ, MD, CSCS
role: PRINCIPAL_INVESTIGATOR
References: