Breast Cancer, Cancer
Conditions
Keywords
Exercise, Resistance Training
Brief summary
In this study, the investigators hypothesize that a high dose of post-workout protein after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone.
Interventions
DIETARY_SUPPLEMENTWhey protein (60 grams)
60 grams of whey protein
OTHERNo protein
0 grams of whey protein
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Age 20-89 years 2. Women prescribed exercise as a SOC 3. Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast 4. Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed. 5. Women with \> 3 months of resistance training experience under expert guidance by a CSCS 6. Must be able to read and understand English and consent for themselves.
Exclusion criteria
1. Any current treatment with cytotoxic chemotherapy for breast cancer 2. Inability to safely engage in group sessions of resistance training as deemed by study PI 3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training 4. Beta blocker or GLP-1 inhibitor medications 5. Pregnant women 6. Males 7. Lactose intolerance 8. Cow's milk or whey protein allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine changes in pounds of muscle and fat mass after each exercise regimen | Baseline and at program completion (within 4 weeks of exercise completion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen | Baseline and at program completion (within 4 weeks of exercise completion) | — |
| Determine changes in body composition at the completion of the exercise regimen, including body mass in pounds, fat mass in pounds, fat-free mass in pounds, % fat, and % fat-free mass | Baseline and at program completion (within 4 weeks of exercise completion) | — |
| Determine changes in Y-balance score at the completion of the exercise regimen | Baseline and at program completion (within 4 weeks of exercise completion) | Y-Balance score measures the length an individual can extend their foot. The larger the score the better the balance. |
| Functional Movement Screen (FMS) scores at the completion of the exercise regimen | Baseline and at program completion (within 4 weeks of exercise completion) | FMS measures movement patterns with scoring from 0 to 21. The large the score the better the mobility. |
| Determine changes in phase angle at the completion of the exercise regimen | At program completion (at 8 weeks) | Phase angle measures the fluidity of cells and the larger the value the better. |
Countries
United States
Contacts
CONTACTClinical Trials Contact
PRINCIPAL_INVESTIGATORColin Champ, MD, CSCS
AHN Radiation Oncology
Outcome results
None listed