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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

NCT ID: NCT06380101Sponsor: University of South FloridaLast updated: 2025-12-10

Summary

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.

Arms & interventions

  • OtherNEAAR Medical Food

    Standardized non-essential amino acid restricted medical food.

Outcome measures

Primary

  • Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea

    Time frame: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Secondary

  • Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema

    Time frame: approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention

  • Absolute and relative change from baseline of circulating non-essential amino acids

    Time frame: from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention

  • Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food

    Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention

  • molecular ctDNA response.

    Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.

Eligibility criteria

Sex: AllAge: 18 Years to 100 YearsHealthy volunteers: No
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

Study locations (1)

University of South Florida

Tampa, Florida, 33606

Recruiting
Jennifer Burgess, MS · Contact
434-806-6445jburgess@tgh.org
Veronique Perry, MSHA · Contact
2549873658vperry@tgh.org
Richard Tuli, MD · Principal Investigator
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) | Cancerify