CancerNCT07704476
EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer
A study testing Whey protein (60 grams) and No protein in people with Cancer and Breast Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 2 sites in United States.
Trial summary
In this study, the investigators hypothesize that a high dose of post-workout protein after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone. 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 (60 grams) and No protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2026to Jun 2028
- 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 prescribed exercise as a SOC
- Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
- Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
- Women with > 3 months of resistance training experience under expert guidance by a CSCS
- Must be able to read and understand English and consent for themselves.
Who cannot join
- Any current treatment with cytotoxic chemotherapy for breast cancer
- Inability to safely engage in group sessions of resistance training as deemed by study PI
- Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
- Beta blocker or GLP-1 inhibitor medications
- Pregnant women
- Males
- Lactose intolerance
- Cow's milk or whey protein allergy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, 412-330-6151, ctgov@ahn.org
- Recruiting
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, 4123306151, ctgov@ahn.org
About this study
Official title: EXERT-BC Protein: Randomized Study of Protein Supplementation to Improve Body Composition Improvement During Hypertrophy Exercise After Treatment for Breast Cancer
In this study, the investigators hypothesize that a high dose of post-workout protein after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone.
- Conditions
- Cancer, Breast Cancer
- Being tested
- Whey protein (60 grams), No protein
- 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 (60 grams)Dietary supplement
60 grams of whey protein
No proteinOther
0 grams of whey protein
| Study group | Role | What they receive |
|---|---|---|
| 60 grams of protein | Experimental | Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 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 (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle). Receives: Dietary Supplement: Whey protein (60 grams) |
| 0 grams of protein | Experimental | Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 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 (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle). Receives: Other: No protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine changes in pounds of muscle and fat mass after each exercise regimen
Measured: Baseline and at program completion (within 4 weeks of exercise completion)
Secondary outcomes (5)
Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen
Measured: Baseline and at program completion (within 4 weeks of exercise completion)
Determine changes in body composition at the completion of the exercise regimen, including body mass in pounds, fat mass in pounds, fat-free mass in pounds, % fat, and % fat-free mass
Measured: Baseline and at program completion (within 4 weeks of exercise completion)
Determine changes in Y-balance score at the completion of the exercise regimen
Y-Balance score measures the length an individual can extend their foot. The larger the score the better the balance.
Measured: Baseline and at program completion (within 4 weeks of exercise completion)
Functional Movement Screen (FMS) scores at the completion of the exercise regimen
FMS measures movement patterns with scoring from 0 to 21. The large the score the better the mobility.
Measured: Baseline and at program completion (within 4 weeks of exercise completion)
Determine changes in phase angle at the completion of the exercise regimen
Phase angle measures the fluidity of cells and the larger the value the better.
Measured: At program completion (at 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start18 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (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
- None (open label)
- Enrolment
- 40 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, CSCS, Principal investigator, AHN Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704476
- Sponsor's protocol ID
- 2026-159-SG
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXERT-BC Protein: Randomized Study of Protein Supplementation to Improve Body Composition Improvement During Hypertrophy Exercise After Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT07704476
- Acronym / sponsor ID
- 2026-159-SG
- Conditions
- Cancer, Breast Cancer
- Keywords
- Exercise, Resistance Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jul 2026 (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 after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 grams of protein | Experimental | Dietary Supplement: Whey protein (60 grams)Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 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 (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle). |
| 0 grams of protein | Experimental | Other: No proteinParticipants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 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 (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle). |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 20-89 years
- Women prescribed exercise as a SOC
- Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
- Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
- Women with > 3 months of resistance training experience under expert guidance by a CSCS
Key exclusion criteria (8 listed)
- Any current treatment with cytotoxic chemotherapy for breast cancer
- Inability to safely engage in group sessions of resistance training as deemed by study PI
- Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
- Beta blocker or GLP-1 inhibitor medications
- Pregnant women
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 (60 grams)60 grams of whey protein | Dietary supplement | 60 grams of protein |
| No protein0 grams of whey protein | Other | 0 grams of protein |
Primary outcome
Determine changes in pounds of muscle and fat mass after each exercise regimen
Time frame: Baseline and at program completion (within 4 weeks of exercise completion)
5 secondary outcomes
Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen
Time frame: Baseline and at program completion (within 4 weeks of exercise completion)
Determine changes in body composition at the completion of the exercise regimen, including body mass in pounds, fat mass in pounds, fat-free mass in pounds, % fat, and % fat-free mass
Time frame: Baseline and at program completion (within 4 weeks of exercise completion)
Determine changes in Y-balance score at the completion of the exercise regimen
Time frame: Baseline and at program completion (within 4 weeks of exercise completion)
Functional Movement Screen (FMS) scores at the completion of the exercise regimen
Time frame: Baseline and at program completion (within 4 weeks of exercise completion)
Determine changes in phase angle at the completion of the exercise regimen
Time frame: At program completion (at 8 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 28 Sep 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, CSCS principal investigator
AHN Radiation Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein (60 grams) and No protein in people with Cancer and Breast Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 2 sites 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 6 inclusion and 8 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Determine changes in pounds of muscle and fat mass after each exercise regimen (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 28 Sep 2026.