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NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer

NCT ID: NCT06858449Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Last updated: 2026-02-03

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.

Arms & interventions

  • Dietary SupplementWhey protein (20 grams)

    20 grams of whey protein

  • Dietary SupplementWhey protein (60 grams)

    60 grams of whey protein.

Outcome measures

Primary

  • 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

  • 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

Sex: FemaleAge: 20 Years to 89 YearsHealthy volunteers: No
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

Study locations (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Recruiting
Clinical Trials Contact · Contact
412-330-6151clinicaltrials@ahn.org
Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer | Cancerify