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

Breast Cancer Clinical Trial

Official title:

EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115486
• Other study ID #: EXERT-BCH
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: Clinical Trials Contact
• Phone: 4123306151
• Email: clinicaltrials[@]ahn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Carcinoma in Situ
• Breast Neoplasms
• Carcinoma in Situ

Intervention

Other:
• Control 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.
• Experimental 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.

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
Secondary	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.	The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.