Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
NCT ID: NCT06380101
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-09-08
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Nonessential Amino Acid Restriction (NEAAR) Medical Food
This is a single arm study in which all subjects will receive NEAAR medical food.
NEAAR Medical Food
Standardized non-essential amino acid restricted medical food.
Interventions
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NEAAR Medical Food
Standardized non-essential amino acid restricted medical food.
Eligibility Criteria
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Inclusion Criteria
* Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI
* Eligible for total mesorectal excision
* No evidence of distant metastasis
* No prior pelvic radiation therapy
* No prior chemotherapy
* Age ≥18 years
Exclusion Criteria
* Other anticancer or experimental therapy
* Body mass index (BMI) \<18.5 kg/m2 or \>40 kg/m2
* Serious or refractive cachexia or anorexia
* 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
18 Years
100 Years
ALL
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Richard R Tuli, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEAAR-LARC
Identifier Type: -
Identifier Source: org_study_id
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