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NCT Number: NCT06858449

Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer

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.

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Key information

Conditions

Cancer Behavior Breast Cancer Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location status: Recruiting

Location contact

Clinical Trials Contact

CONTACT

[email protected]

412-330-6151

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey protein (20 grams)

Dietary Supplement

20 grams of whey protein

Whey protein (60 grams)

Dietary Supplement

60 grams of whey protein.

Primary outcomes

  1. 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 outcomes

  1. 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)

    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.

  2. 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).

    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.

  3. 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).

    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.

  4. 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).

    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.

  5. 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).

    Godin Leisure-Time Exercise Questionnaire is used to measure a person's frequency and intensity of exercise during a typical week. A Godin Scale Score of 24 units or more is interpreted as Active, 14 - 23 units is Moderately Active, and less than 14 units is Insufficiently Active/Sedentary.

  6. Changes in resting metabolic rate at completion of chemotherapy

    Time frame: Baseline and at program completion (within 4 weeks of exercise completion).

  7. 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).

  8. 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).

    Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.

  9. 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).

    During the test, 7 movement patterns are assessed and each one is rated between 0 and 3 by an examiner. These movements include the deep squat, hurdle step, inline lunge, shoulder mobility test, active straight leg raise, trunk stability push up, and rotary stability test. A score of zero is given if any pain is felt during the movement, 1 if the subject is unable to perform the movement, 2 if the subject performs the movement through compensatory movements, and 3 if the movement is performed correctly. Each movement score is summed and a final score out of 21 is calculated. A score below 14 is felt to identify individuals at risk of injury.

  10. Changes in phase angle at completion of chemotherapy

    Time frame: At program completion (at 24 weeks)

    Phase angle is calculated via bioimpedance analysis and is measured in degrees.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Contact

CONTACT

[email protected]

412-330-6151

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Registry information

Official study title

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

Acronym: NeoChemoPRT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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