Recruiting

Resistance Training & Protein

Sponsor:

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

Code:

NCT06858449

Conditions

Cancer

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Whey protein (20 grams)

Whey protein (60 grams)

Study Details

Brief summary:

In this study, the investigators hypothesize that a high dose of post-workout protein nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.

Conditions

Cancer

Breast Cancer

Study ID

NCT06858449

Start date

Jan 2, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 20-89 years
2. Women with a biopsy proven diagnosis of invasive carcinoma of the breast.
3. Women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery
4. Must be able to read and understand English and consent for themselves.

Exclusion Criteria:

1. Inability to get up and down off the ground or squat body weight
2. Inability to safely engage in group exercise sessions as deemed by study PI
3. Severe arthritic, joint, cardiovascular, musculoskeletal, or any other condition deemed by PI to be unsafe to engage in resistance training
4. Lactose intolerance
5. Cow's milk or whey protein allergy
6. Pregnant women
7. Males

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 20 grams of protein

Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 20 grams of whey protein. The protein will be 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, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.

experimental: 60 grams of protein

Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 60 grams of whey protein. The protein will be 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, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.

Interventions

Whey protein (20 grams)

20 grams of whey protein

Whey protein (60 grams)

60 grams of whey protein.

Primary outcome measure

  • Changes in muscle mass and fat mass (pounds) at completion of chemotherapy [ Time Frame: Baseline and at program completion (within 4 weeks of exercise completion). ]

Central Contacts and Locations

Central contacts

Clinical Trials Contact

412-330-6151ctgov@ahn.org

Locations

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Clinical Trials Contact

412-330-6151clinicaltrials@ahn.org

More Information

Sponsor

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

Last update posted

Feb 3, 2026

Last verified

Feb, 2026

Keywords

  • exercise
  • resistance training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-02-03.