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NCT Number: NCT07704476

EXERT-BC Protein: Protein Supplementation to Improve Body Composition 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.

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Key information

Conditions

Cancer Behavior Breast Cancer Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location contact

Clinical Trials Contact

CONTACT

[email protected]

412-330-6151

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey protein (60 grams)

Dietary Supplement

60 grams of whey protein

No protein

Other

0 grams of whey protein

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Contact

CONTACT

[email protected]

412-330-6151

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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