Recruiting NCT06858449
Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whey protein (20 grams), Whey protein (60 grams).
- Who it may be relevant to
- Registry conditions: Cancer, Breast Cancer. Basic parameters: 20 years — 89 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
Overview
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.
Interventions
- Dietary supplement Whey protein (20 grams)
20 grams of whey protein - Dietary supplement Whey protein (60 grams)
60 grams of whey protein.
Primary outcome measures
- 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 outcome measures (10)
- Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).]
- Changes in activity levels via Godin Leisure-Time Exercise Questionnaire [Time frame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).]
- Changes in resting metabolic rate at completion of chemotherapy [Time frame: 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. [Time frame: Baseline and at program completion (within 4 weeks of exercise completion).]
- Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy [Time frame: Baseline and at program completion (within 4 weeks of exercise completion).]
- Changes in Functional Mobility Score at baseline and at completion of chemotherapy [Time frame: Baseline and at program completion (within 4 weeks of exercise completion).]
- Changes in phase angle at completion of chemotherapy [Time frame: At program completion (at 24 weeks)]
Eligibility criteria
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
- Males
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Allegheny General Hospital — Pittsburgh
Identifiers
NCT: NCT06858449 · 2024-149-SG