[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545299":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":58,"collaborators":19,"id":60,"slug":19,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":19,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":19,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of South Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nonessential Amino Acid Restriction (NEAAR) Medical Food","EXPERIMENTAL","This is a single arm study in which all subjects will receive NEAAR medical food.",[13],"Other: NEAAR Medical Food",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"NEAAR Medical Food","Standardized non-essential amino acid restricted medical food.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Richard R Tuli, MD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","813 844 7585","rtuli@usf.edu",{"name":30,"role":26,"phone":31,"phoneExt":19,"email":32},"Keira O'Connor","813 844 8486","keiraoconnor@usf.edu",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Tampa","Florida","33606","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-82.45843,27.94752,{"lat":45,"lon":44},[48,52,56],{"name":49,"role":26,"phone":50,"phoneExt":19,"email":51},"Jennifer Burgess, MS","434-806-6445","jburgess@tgh.org",{"name":53,"role":26,"phone":54,"phoneExt":19,"email":55},"Veronique Perry, MSHA","2549873658","vperry@tgh.org",{"name":57,"role":23,"phone":19,"phoneExt":19,"email":19},"Richard Tuli, MD",{"type":59,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100545299",false,"NCT06380101","Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)","Prospective, Single Arm IIA Study to Evaluate the Feasibility of a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food in Combination With Total Neoadjuvant Therapy (TNT) for Management of Locally Advanced Rectal Cancer (LARC) NEAAR-LARC","NEAAR-LARC","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the rectum\n* Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI\n* Eligible for total mesorectal excision\n* No evidence of distant metastasis\n* No prior pelvic radiation therapy\n* No prior chemotherapy\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Patients unable to undergo MRI\n* Other anticancer or experimental therapy\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm2 or \\>40 kg\u002Fm2\n* Serious or refractive cachexia or anorexia\n* Insulin-dependent diabetes Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®) Patients with a condition where high-fat or fatty food is contraindicated History of confirmed food allergy Active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing","ALL","18 Years","100 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"NA","This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.",[78],"Rectal Cancer","2025-12-03",{"date":81,"type":82},"2025-12-10","ACTUAL",{"date":84,"type":82},"2023-09-08",{"date":86,"type":72},"2027-06",{"name":5,"class":6},1]