[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598030":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":57,"studyPopulation":50,"armGroups":58,"interventions":69,"overallOfficials":74,"centralContacts":78,"locations":83,"responsibleParty":100,"collaborators":102,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":50,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":50,"enrollmentInfo":114,"targetDuration":50,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":85,"whyStopped":50,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Yale University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Pathologic Complete Response (pCR)","Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0\u002Fis ypN0)","Post breast cancer surgery, an average of 6 months",[14],{"measure":15,"description":16,"timeFrame":12},"Residual Cancer Burden (RCB)","Residual Cancer Burden (RCB) is a continuous pCR measure.",[18,22,25,28,31,33,36,39,42,45],{"measure":19,"description":20,"timeFrame":21},"Healthy Eating Index (HEI)","Healthy Eating Index (HEI) will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center.","Baseline to end of first line chemotherapy, on average 6 months",{"measure":23,"description":24,"timeFrame":21},"Physical activity","Self-reported minutes per week of moderate- to vigorous-intensity physical activity will be estimated using the modifiable physical activity questionnaire.",{"measure":26,"description":27,"timeFrame":21},"Patient reported toxicities","Participants will be asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey at baseline, 2-months, 4-months and the end of chemotherapy.",{"measure":29,"description":30,"timeFrame":21},"Physical function","Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.",{"measure":32,"description":30,"timeFrame":21},"Fatigue",{"measure":34,"description":35,"timeFrame":21},"Neuropathy","Participants will be asked to complete the Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-Ntx).",{"measure":37,"description":38,"timeFrame":21},"Malnutrition","Participants will be asked to complete the Patient-Generated Subjective Global Assessment (PG-SGA).",{"measure":40,"description":41,"timeFrame":21},"Aerobic capacity","Participants will be asked to complete a 6-minute walk test.",{"measure":43,"description":44,"timeFrame":21},"Lean mass","Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan",{"measure":46,"description":44,"timeFrame":21},"Percent fat",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":50,"timePerspective":50,"maskingInfo":52},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":53,"maskingDescription":54,"whoMasked":55},"SINGLE","The following study personnel will be masked to participant study arm: the staff performing DXA scan and blood processing\u002Fbiomarker evaluation. The staff performing clinic measures, study staff reviewing forms and entering data, the PI and Co-Is, the statistician, study manager, and interventionists will be unblinded.",[56],"OUTCOMES_ASSESSOR","Women with stage II-III triple-negative breast cancer (TNBC) undergoing neoadjuvant chemo-immunotherapy will be enrolled in the study. Following screening, consent, and baseline assessment, participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. Participants randomized to the intervention group will complete weekly remote sessions with the interventionist throughout the duration of chemotherapy. Each counseling session will last about 30 minutes and will be conducted remotely. The exercise regimen is home-based.\n\nStudy activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition.\n\nThe primary outcome is the pathologic complete response.\n\nResearchers will also compare the exercise and nutrition program to usual care to determine if the program improves residual cancer burden, symptoms related to cancer treatment, body composition, and blood biomarkers.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Exercise and Medical Nutrition","EXPERIMENTAL","Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion.",[64],"Behavioral: Exercise and Medical Nutrition",{"label":66,"type":67,"description":68,"interventionNames":50},"Usual care","NO_INTERVENTION","Contact limited to study assessments.",[70],{"type":71,"name":60,"description":72,"armGroupLabels":73,"otherNames":50},"BEHAVIORAL","10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.",[60],[75],{"name":76,"affiliation":5,"role":77},"Melinda Irwin","PRINCIPAL_INVESTIGATOR",[79],{"name":76,"role":80,"phone":81,"phoneExt":50,"email":82},"CONTACT","203-785-6392","melinda.irwin@yale.edu",[84],{"facility":5,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-72.92816,41.30815,{"lat":95,"lon":94},[98],{"name":99,"role":80,"phone":81,"phoneExt":50,"email":82},"Melinda Irwin, PhD",{"type":101,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[103],{"name":104,"class":6},"Breast Cancer Research Foundation","100598030","lifestyle-exercise-and-nutrition-lean-trial-on-pathologic-complete-response-in-tnbc-100598030",false,"NCT07066189","Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC","Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n1. Female aged 18 years or older.\n2. Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).\n3. Be scheduled to receive neoadjuvant chemo-immunotherapy.\n4. Be physically able to walk.\n5. Be able to complete forms, understand instructions and read in English.\n6. Agree to be randomly assigned to either group.\n7. Have clearance from oncologist to participate.\n8. Not exercising (less than 150 min\u002Fweek).\n9. Not consuming more than 7 fruits and vegetable\u002Fday.\n\nExclusion Criteria:\n\n1. Having already started a 2nd chemotherapy cycle.\n2. Pregnancy or intention to become pregnant.\n3. Presence of dementia or major psychiatric disease.\n4. Recent (past year) stroke, myocardial infarction, or congestive heart failure.","FEMALE","18 Years",{"count":115,"type":116},160,"ESTIMATED","INTERVENTIONAL",[119],"NA","The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.",[122],"Triple Negative Breast Cancer",[124,125,126,127],"Exercise","Diet","Pathologic complete response","Neoadjuvant therapy","2026-09-21",{"date":130,"type":131},"2026-09-25","ACTUAL",{"date":133,"type":131},"2025-10-17",{"date":135,"type":116},"2029-10",{"name":5,"class":6},1]