About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Whey protein (20 grams)
Dietary supplement20 grams of whey protein
Whey protein (60 grams)
Dietary supplement60 grams of whey protein.
Treatment groups
Trial outcomes
Primary outcomes
Changes in muscle mass and fat mass (pounds) at completion of chemotherapy
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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