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

Description

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.

Conditions

Rectal Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Rectal Cancer
Intervention / Treatment

-

Contacts and Locations

Tampa

University of South Florida, Tampa, Florida, United States, 33606

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of South Florida,

Richard R Tuli, MD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

2025-06