Clinical trial NCT06858449: Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
Official title: NeoChemoPRT: a Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Breast Cancer
Keywords: exercise
resistance training
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in muscle mass and fat mass (pounds) at completion of chemotherapy
timeFrame: Baseline and at program completion (within 4 weeks of exercise completion).
Secondary outcomes:
measure: Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)
timeFrame: Chemotherapy response assessment is at program completion (within 4 weeks of exercise completion)
measure: Changes in EuroQol-5 Dimensions (EQ-5D) at completion of chemotherapy assessment
timeFrame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
measure: Changes in Patient Health Questionnaire-9 (PHQ9) depression score at completion of chemotherapy assessment
timeFrame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
measure: Changes in General Anxiety Disorder-7 (GAD7) anxiety score at completion of chemotherapy assessment
timeFrame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
measure: Changes in activity levels via Godin Leisure-Time Exercise Questionnaire
timeFrame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
measure: Changes in resting metabolic rate at completion of chemotherapy
timeFrame: Baseline and at program completion (within 4 weeks of exercise completion).
measure: Changes in body composition at completion of chemotherapy, including fat-free mass in pounds.
timeFrame: Baseline and at program completion (within 4 weeks of exercise completion).
measure: Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy
timeFrame: Baseline and at program completion (within 4 weeks of exercise completion).
measure: Changes in Functional Mobility Score at baseline and at completion of chemotherapy
timeFrame: Baseline and at program completion (within 4 weeks of exercise completion).
measure: Changes in phase angle at completion of chemotherapy
timeFrame: At program completion (at 24 weeks)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: AHN Radiation Oncology
name: Colin Champ, MD
role: PRINCIPAL_INVESTIGATOR
References: