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

December 3, 2025 updated by: University of South Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Richard R Tuli, MD
  • Phone Number: 813 844 7585
  • Email: rtuli@usf.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
          • Veronique Perry, MSHA
          • Phone Number: 2549873658
          • Email: vperry@tgh.org
        • Principal Investigator:
          • Richard Tuli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food
This is a single arm study in which all subjects will receive NEAAR medical food.
Other: NEAAR Medical Food
Standardized non-essential amino acid restricted medical food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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.
approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Richard R Tuli, MD, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEAAR-LARC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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