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Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)

RecruitingNAAges 18 Years - 100 YearsAllUniversity of South Florida
NCT06380101 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the rectum * 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: * Patients unable to undergo MRI * 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
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What it tests

  • NEAAR Medical Food
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Where

1 site
University of South Florida
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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