ClinicalTrials.gg
RecruitingNCT07704476Updated Sep 28, 2026

EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer

An interventional study of Whey protein (60 grams) and No protein in Cancer and Breast Cancer, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 2 sites in United States. Open to female participants aged 20 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Primary conditionBreast NeoplasmsRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Breast Neoplasms
Why
  1. The study's listed conditions name Breast Neoplasms, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Sep 28, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 89 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cancer
  • Breast Cancer

Browse trials for

Keywords

  • Exercise
  • Resistance Training
03

In context

Breast Neoplasms Reclassified

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 49 studies on the registry; 20 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Compared within Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 20-89 years
  2. Women prescribed exercise as a SOC
  3. Women with a proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
  4. 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.
  5. Women with > 3 months of resistance training experience under expert guidance by a CSCS
  6. Must be able to read and understand English and consent for themselves.

Exclusion criteria

Exclusion Criteria:

  1. Any current treatment with cytotoxic chemotherapy for breast cancer
  2. Inability to safely engage in group sessions of resistance training as deemed by study PI
  3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
  4. Beta blocker or GLP-1 inhibitor medications
  5. Pregnant women
  6. Males
  7. Lactose intolerance
  8. Cow's milk or whey protein allergy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    60 grams of protein

    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).

    Dietary Supplement: Whey protein (60 grams)

  • Experimental
    0 grams of protein

    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).

    Other: No protein

Interventions

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

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

  4. 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.

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

  5. 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.

    Time frame: At program completion (at 8 weeks)

07

Study locations

1 of 2 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 12 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Mar 2027 → Jun 2027 and completion Jun 2027 → Jun 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Jul 15, 2026
StartActual
Jun 18, 2026
Primary completionEst.
Jun 2027was Mar 2027
CompletionEst.
Jun 2028was Jun 2027
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
1 site added. AHN Allegheny General Hospital is now Not yet recruiting
Show site
  • AHN Allegheny General Hospital · Pittsburgh, United States
Sep 28, 2026
Primary completion
Mar 2027→Jun 2027
Sep 28, 2026
Study completion
Jun 2027→Jun 2028
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    1 site added. AHN Allegheny General Hospital is now Not yet recruiting
    Show site
    • AHN Allegheny General Hospital · Pittsburgh, United States
    Primary completion Mar 2027→Jun 2027
    Study completion Jun 2027→Jun 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07704476
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Responsible party
Colin Champ, MD (Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)) — Principal investigator
First posted
Jul 15, 2026
Start date
Jun 18, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Clinical Trials Contact
Contact
ctgov@ahn.org
412-330-6151
Colin Champ, MD, CSCS
principal investigator · AHN Radiation Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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