Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer (NeoChemoPRT)

Allegheny Health Network (AHN)

Status: Enrolling

Conditions: Breast Cancer; Cancer

Treatments: Dietary Supplement: Whey protein (60 grams); Dietary Supplement: Whey protein (20 grams)

Study type: Interventional

Funder types: Other

Identifiers

NCT06858449

2024-149-SG

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

20 grams of protein

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Whey protein (20 grams)

60 grams of protein

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Whey protein (60 grams)