[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07704476":3,"trial-entities:NCT07704476":96,"trial-summary:NCT07704476":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":14,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":46,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":87,"overall_officials":89,"references":94,"see_also_links":95},"NCT07704476","2026-159-SG","EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer","EXERT-BC Protein: Randomized Study of Protein Supplementation to Improve Body Composition Improvement During Hypertrophy Exercise After Treatment for Breast Cancer","NOT_YET_RECRUITING","2027-06","2026-07","2026-07-15","2026-06","Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)","OTHER",false,"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.",null,[19,20],"Cancer","Breast Cancer",[22,23],"Exercise","Resistance Training","INTERVENTIONAL",[26],"NA",{"count":28,"type":29},40,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIETARY_SUPPLEMENT","Whey protein (60 grams)","60 grams of whey protein",[36],"60 grams of protein",{"type":14,"name":38,"description":39,"armGroupLabels":40},"No protein","0 grams of whey protein",[41],"0 grams of protein",[43],{"measure":44,"timeFrame":45},"Determine changes in pounds of muscle and fat mass after each exercise regimen","Baseline and at program completion (within 4 weeks of exercise completion)",[47,49,51,54,57],{"measure":48,"timeFrame":45},"Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen",{"measure":50,"timeFrame":45},"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",{"measure":52,"description":53,"timeFrame":45},"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.",{"measure":55,"description":56,"timeFrame":45},"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.",{"measure":58,"description":59,"timeFrame":60},"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.","At program completion (at 8 weeks)","FEMALE","20 Years","89 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Age 20-89 years\n2. Women prescribed exercise as a SOC\n3. Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast\n4. 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.\n5. Women with \\> 3 months of resistance training experience under expert guidance by a CSCS\n6. Must be able to read and understand English and consent for themselves.\n\nExclusion Criteria:\n\n1. Any current treatment with cytotoxic chemotherapy for breast cancer\n2. Inability to safely engage in group sessions of resistance training as deemed by study PI\n3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training\n4. Beta blocker or GLP-1 inhibitor medications\n5. Pregnant women\n6. Males\n7. Lactose intolerance\n8. Cow's milk or whey protein allergy",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":84},"AHN Allegheny General Hospital","Pittsburgh","Pennsylvania","15212","United States",[79],{"name":80,"role":81,"phone":82,"email":83},"Clinical Trials Contact","CONTACT","412-330-6151","ctgov@ahn.org",{"lat":85,"lon":86},40.44062,-79.99589,[88],{"name":80,"role":81,"phone":82,"email":83},[90],{"name":91,"affiliation":92,"role":93},"Colin Champ, MD, CSCS","AHN Radiation Oncology","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Breast Carcinoma",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This interventional study plans to enroll 40 women. It compares the effects of whey protein versus no protein after exercise.","completed","Protein Supplementation for Body Composition After Breast Cancer Treatment","This study is looking at whether adding 60 grams of whey protein after exercise can help women who have been treated for breast cancer improve their body composition, specifically by gaining more muscle and reducing body fat. You may be able to join if you are a woman between 20 and 89 years old, have been diagnosed with ductal carcinoma in situ (DCIS) or invasive breast cancer, and have received treatment like surgery, radiation, chemotherapy, immunotherapy, or hormonal therapy. The researchers want to see if the protein supplement leads to better changes in muscle and fat compared to exercise alone. The study is currently unclear on its recruitment status and plans to enroll 40 participants.","Changes in muscle and fat mass will be measured at the beginning of the study and within 4 weeks of completing the exercise program.",115,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]