Not yet recruiting NCT07704476
EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whey protein (60 grams), No protein.
- Who it may be relevant to
- Registry conditions: Cancer, Breast Cancer. Basic parameters: 20 years — 89 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EXERT-BC Protein: Randomized Study of Protein Supplementation to Improve Body Composition Improvement During Hypertrophy Exercise After Treatment for Breast Cancer
Overview
In this study, the investigators hypothesize that a high dose of post-workout protein after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone.
Interventions
- Dietary supplement Whey protein (60 grams)
60 grams of whey protein - Other No protein
0 grams of whey protein
Primary outcome measures
- Determine changes in pounds of muscle and fat mass after each exercise regimen [Time frame: Baseline and at program completion (within 4 weeks of exercise completion)]
Secondary outcome measures (5)
- Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen [Time frame: Baseline and at program completion (within 4 weeks of exercise completion)]
- Determine changes in body composition at the completion of the exercise regimen, including body mass in pounds, fat mass in pounds, fat-free mass in pounds, % fat, and % fat-free mass [Time frame: Baseline and at program completion (within 4 weeks of exercise completion)]
- Determine changes in Y-balance score at the completion of the exercise regimen [Time frame: Baseline and at program completion (within 4 weeks of exercise completion)]
- Functional Movement Screen (FMS) scores at the completion of the exercise regimen [Time frame: Baseline and at program completion (within 4 weeks of exercise completion)]
- Determine changes in phase angle at the completion of the exercise regimen [Time frame: At program completion (at 8 weeks)]
Eligibility criteria
Inclusion criteria
- Age 20-89 years
- Women prescribed exercise as a SOC
- Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) 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.
- Women with > 3 months of resistance training experience under expert guidance by a CSCS
- Must be able to read and understand English and consent for themselves.
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
- Beta blocker or GLP-1 inhibitor medications
- Pregnant women
- Males
- Lactose intolerance
- Cow's milk or whey protein allergy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- AHN Allegheny General Hospital — Pittsburgh
Identifiers
NCT: NCT07704476 · 2026-159-SG