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

July 14, 2026 updated by: Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Trials Contact
  • Phone Number: 412-330-6151
  • Email: ctgov@ahn.org

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • AHN Allegheny General Hospital
        • Contact:
          • Clinical Trials Contact
          • Phone Number: 412-330-6151
          • Email: ctgov@ahn.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 60 grams of 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).
Dietary supplement: Whey protein (60 grams)
60 grams of whey protein
Experimental: 0 grams of 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).
Other: No protein
0 grams of whey protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline and at program completion (within 4 weeks of exercise completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Y-Balance score measures the length an individual can extend their foot. The larger the score the better the balance.
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)
FMS measures movement patterns with scoring from 0 to 21. The large the score the better the mobility.
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)
Phase angle measures the fluidity of cells and the larger the value the better.
At program completion (at 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigators

  • Principal Investigator: Colin Champ, MD, CSCS, AHN Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-159-SG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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