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

NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Breast Cancer
• Intervention / Treatment: Dietary supplement: Whey protein (20 grams); Dietary supplement: Whey protein (60 grams)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• 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
      • Recruiting
      • Allegheny General Hospital
      • Contact: Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Whey protein (20 grams); 20 grams of whey protein
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.	Dietary supplement: Whey protein (60 grams); 60 grams of whey protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in muscle mass and fat mass (pounds) at completion of chemotherapy	Baseline and at program completion (within 4 weeks of exercise completion).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)	Response to chemotherapy will be assessed via the guidelines or the Response evaluation criteria in solid tumors (RECIST) criteria version 1.1 before and after chemotherapy with radiographic interpretation on either MRI of the breast or, if unable to get an MRI, PET/CT scan.	Chemotherapy response assessment is at program completion (within 4 weeks of exercise completion)
Changes in EuroQol-5 Dimensions (EQ-5D) at completion of chemotherapy assessment	EuroQol-5 Dimensions-5 Levels total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). This is calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes.	Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in Patient Health Questionnaire-9 (PHQ9) depression score at completion of chemotherapy assessment	Patient Health Questionnaire-9 total score for the 9 questions ranges from 0 (no depression) to 27 (highest level of depression). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.	Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in General Anxiety Disorder-7 (GAD7) anxiety score at completion of chemotherapy assessment	General Anxiety Disorder-7 total score for the seven questions ranges from 0 (no anxiety) to 21 (highest level of anxiety). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.	Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in activity levels via Godin Leisure-Time Exercise Questionnaire	Godin Leisure-Time Exercise Questionnaire is used to measure a person's frequency and intensity of exercise during a typical week. A Godin Scale Score of 24 units or more is interpreted as Active, 14 - 23 units is Moderately Active, and less than 14 units is Insufficiently Active/Sedentary.	Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in resting metabolic rate at completion of chemotherapy		Baseline and at program completion (within 4 weeks of exercise completion).
Changes in body composition at completion of chemotherapy, including fat-free mass in pounds.		Baseline and at program completion (within 4 weeks of exercise completion).
Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy	Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.	Baseline and at program completion (within 4 weeks of exercise completion).
Changes in Functional Mobility Score at baseline and at completion of chemotherapy	During the test, 7 movement patterns are assessed and each one is rated between 0 and 3 by an examiner. These movements include the deep squat, hurdle step, inline lunge, shoulder mobility test, active straight leg raise, trunk stability push up, and rotary stability test. A score of zero is given if any pain is felt during the movement, 1 if the subject is unable to perform the movement, 2 if the subject performs the movement through compensatory movements, and 3 if the movement is performed correctly. Each movement score is summed and a final score out of 21 is calculated. A score below 14 is felt to identify individuals at risk of injury.	Baseline and at program completion (within 4 weeks of exercise completion).
Changes in phase angle at completion of chemotherapy	Phase angle is calculated via bioimpedance analysis and is measured in degrees.	At program completion (at 24 weeks)

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Investigators: Principal Investigator: Colin Champ, MD, AHN Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise; resistance training
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms; Motor Activity; Amino Acids, Peptides, and Proteins; Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dairy Products; Milk; Dietary Proteins; Milk Proteins; Animal Proteins, Dietary; Whey; Whey Proteins
• Other Study ID Numbers: 2024-149-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
• product manufactured in and exported from the U.S.: No