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

NCT07704476 | Not Yet Recruiting

• 1 other identifier: 2026-159-SG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Breast Cancer

Keywords

Exercise; Resistance Training

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• 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)

• Functional Movement Screen (FMS) scores at the completion of the exercise regimen

  Baseline and at program completion (within 4 weeks of exercise completion)

• Determine changes in phase angle at the completion of the exercise regimen

  At program completion (at 8 weeks)

Study Arms (2)

60 grams of protein

EXPERIMENTAL

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).

Dietary Supplement: Whey protein (60 grams)

0 grams of protein

EXPERIMENTAL

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).

Other: No protein

Interventions

Whey protein (60 grams) DIETARY_SUPPLEMENT

60 grams of whey protein

60 grams of protein

No protein OTHER

0 grams of whey protein

0 grams of protein

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Motor Activity

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Colin Champ, MD, CSCS

  AHN Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

412-330-6151; ctgov@ahn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)