NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in muscle mass and fat mass (pounds) at completion of chemotherapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 89 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 20-89 years
- •Women with a biopsy proven diagnosis of invasive carcinoma of the breast.
- •Women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery
- •Must be able to read and understand English and consent for themselves.
Exclusion Criteria
- •Inability to get up and down off the ground or squat body weight
- •Inability to safely engage in group exercise sessions as deemed by study PI
- •Severe arthritic, joint, cardiovascular, musculoskeletal, or any other condition deemed by PI to be unsafe to engage in resistance training
- •Lactose intolerance
- •Cow's milk or whey protein allergy
- •Pregnant women
Arms & Interventions
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.
Intervention: Whey protein (20 grams) (Dietary Supplement)
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.
Intervention: Whey protein (60 grams) (Dietary Supplement)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)(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(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(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(Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).)
- Changes in activity levels via Godin Leisure-Time Exercise Questionnaire(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(Baseline and at program completion (within 4 weeks of exercise completion).)
- Changes in Functional Mobility Score at baseline and at completion of chemotherapy(Baseline and at program completion (within 4 weeks of exercise completion).)
- Changes in phase angle at completion of chemotherapy(At program completion (at 24 weeks))
Investigators
Colin Champ, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)