Clinical trial NCT07023887: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning
Official title: EXERT-BCHC: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Breast Cancer
Keywords: exercise
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited via convenience sampling from the Study Investigators' practice patient population, referrals from other physicians' practices, or identifiable medical record review (e.g., EPIC).

Brief summary: This study investigates the impact of four standard of care, monitored group exercise regimens (resistance training) on conditioning and hypertrophy in women previously treated for breast cancer. The study will compare two conditioning regimens (6-12-25 and 8x8) and two hypertrophy regimens (5/5/5 cluster sets and double training) to assess changes in VO2 max, muscle mass, and fat mass.


Eligibility criteria: Inclusion Criteria:

1. Age 20-89 years
2. Women prescribed exercise as a Standard of Care
3. Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
4. Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy.
5. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
6. Women with \> 6 months of resistance training experience under expert guidance by a CSCS

Exclusion Criteria:

1. Any current treatment with cytotoxic chemotherapy for breast cancer
2. Inability to safely engage in group sessions of resistance training as deemed by study Pl
3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by Pl to be unsafe to engage in resistance training
4. Beta blocker or GLP-1 inhibitor medications
5. Pregnant women
6. Males

Primary outcomes:
measure: Change in VO2 max
timeFrame: Measured monthly during the 5-month exercise program at weeks 4, 8, 12, 16, and 20.
measure: Change in Muscle and Fat Mass
timeFrame: Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
measure: Change in Muscle and Fat Mass
timeFrame: Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
Secondary outcomes:
measure: Change in Hand Grip Strength
timeFrame: Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
measure: Change in Psychology Questionnaire Scores
timeFrame: Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: AHN Radiation Oncology
name: Colin Champ
role: PRINCIPAL_INVESTIGATOR
References: