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

NCT06858449 | Recruiting DMC

• 1 other identifier: 2024-149-SG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Breast Cancer

Keywords

exercise; resistance training

Outcome Measures

Primary Outcomes (1)

• Changes in muscle mass and fat mass (pounds) at completion of chemotherapy

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

Secondary Outcomes (10)

• Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)

  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

  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

  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

  Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).

• Changes in activity levels via Godin Leisure-Time Exercise Questionnaire

  Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).

Study Arms (2)

20 grams of protein

EXPERIMENTAL

Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 20 grams of whey protein. The protein will be 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.

Dietary Supplement: Whey protein (20 grams)

60 grams of protein

EXPERIMENTAL

Participants will be randomized (like flipping a coin) to a post-workout protein consisting of 60 grams of whey protein. The protein will be 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy, which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Participants will not know which amount of protein they receive.

Dietary Supplement: Whey protein (60 grams)

Interventions

Whey protein (20 grams) DIETARY_SUPPLEMENT

20 grams of whey protein

20 grams of protein

Whey protein (60 grams) DIETARY_SUPPLEMENT

60 grams of whey protein.

60 grams of protein

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Motor Activity

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Colin Champ, MD

  AHN Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

412-330-6151; ctgov@ahn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 5, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

US (1)