CancerNeoChemoPRTNCT06858449
Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
A study testing Whey protein (20 grams) and Whey protein (60 grams) in people with Cancer and Breast Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 89 years, women only
- Conditions the study is for
- Cancer, Breast Cancer
- What is being tested?
- Whey protein (20 grams) and Whey protein (60 grams)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, 412-330-6151, clinicaltrials@ahn.org
About this study
Official title: NeoChemoPRT: A Randomized Study of 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.
- Conditions
- Cancer, Breast Cancer
- Being tested
- Whey protein (20 grams), Whey protein (60 grams)
- Keywords
- exercise, resistance training
- Medical subject headings
- Neoplasms, Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein (20 grams)Dietary supplement
20 grams of whey protein
Whey protein (60 grams)Dietary supplement
60 grams of whey protein.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Whey protein (60 grams) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle mass and fat mass (pounds) at completion of chemotherapy
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in activity levels via Godin Leisure-Time Exercise Questionnaire
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.
Measured: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in resting metabolic rate at completion of chemotherapy
Measured: 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.
Measured: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy
Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.
Measured: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in Functional Mobility Score at baseline and at completion of chemotherapy
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.
Measured: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in phase angle at completion of chemotherapy
Phase angle is calculated via bioimpedance analysis and is measured in degrees.
Measured: At program completion (at 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start2 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Colin Champ, MD, Principal investigator, AHN Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858449
- Sponsor's protocol ID
- 2024-149-SG
- Acronym
- NeoChemoPRT
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoChemoPRT: A Randomized Study of Resistance Training and Post-Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT06858449
- Acronym / sponsor ID
- NeoChemoPRT / 2024-149-SG
- Conditions
- Cancer, Breast Cancer
- Keywords
- exercise, resistance training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 grams of protein | Experimental | Dietary Supplement: Whey protein (20 grams)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. |
| 60 grams of protein | Experimental | Dietary Supplement: Whey protein (60 grams)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. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein (20 grams)20 grams of whey protein | Dietary supplement | 20 grams of protein |
| Whey protein (60 grams)60 grams of whey protein. | Dietary supplement | 60 grams of protein |
Primary outcome
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).
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Champ, MD principal investigator
AHN Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein (20 grams) and Whey protein (60 grams) in people with Cancer and Breast Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Contact (412-330-6151, ctgov@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.