EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer

NCT07704476 — Not applicable, Recruiting, 40 participants, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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EXERT-BC Protein: Randomized Study of Protein Supplementation to Improve Body Composition Improvement During Hypertrophy Exercise After Treatment for Breast Cancer

Registry	NCT07704476
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	40 (Estimated)
Sponsor	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (Other)
Conditions	Cancer, Breast Cancer
Interventions	Whey protein (60 grams), No protein (Dietary supplement, other)
Dates	start 2026-06-18, primary completion 2027-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-07-15, last updated 2026-09-28
Locations	2 sites in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
60 grams of protein	Experimental	Dietary Supplement: Whey protein (60 grams)	Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle).
0 grams of protein	Experimental	Other: No protein	Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle).

Whey protein (60 grams) (Dietary supplement): 60 grams of whey protein
No protein (Other): 0 grams of whey protein

+Outcome measures

Primary outcomes

Determine changes in pounds of muscle and fat mass after each exercise regimen [Baseline and at program completion (within 4 weeks of exercise completion)]

Secondary outcomes

Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen [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 [Baseline and at program completion (within 4 weeks of exercise completion)]
Determine changes in Y-balance score at the completion of the exercise regimen [Baseline and at program completion (within 4 weeks of exercise completion)]: Y-Balance score measures the length an individual can extend their foot. The larger the score the better the balance.
Functional Movement Screen (FMS) scores at the completion of the exercise regimen [Baseline and at program completion (within 4 weeks of exercise completion)]: FMS measures movement patterns with scoring from 0 to 21. The large the score the better the mobility.
Determine changes in phase angle at the completion of the exercise regimen [At program completion (at 8 weeks)]: Phase angle measures the fluidity of cells and the larger the value the better.

+Eligibility

Sex: Female, ages: 20 Years to 89 Years

Inclusion Criteria:

1. Age 20-89 years
2. Women prescribed exercise as a SOC
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. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
5. Women with > 3 months of resistance training experience under expert guidance by a CSCS
6. Must be able to read and understand English and consent for themselves.

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 PI
3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
4. Beta blocker or GLP-1 inhibitor medications
5. Pregnant women
6. Males
7. Lactose intolerance
8. Cow's milk or whey protein allergy

+Locations (2)

Facility	City	Country	Status
AHN Allegheny General Hospital	Pittsburgh, Pennsylvania	United States	Not yet recruiting
AHN Allegheny General Hospital	Pittsburgh, Pennsylvania	United States	Recruiting

+Investigators

Colin Champ, MD, CSCS, Principal investigator, AHN Radiation Oncology