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

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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

Study Start (Actual) 2023-09-08

Primary Completion (Estimated) 2024-12

Study Completion (Estimated) 2025-06

Enrollment (Estimated) 30

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Tampa, Florida, United States

Eligibility Criteria

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

Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

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 Registration Dates

First Submitted2024-04-18
First Submitted that Met QC Criteria2024-04-18
First Posted2024-04-23

Study Record Updates

Last Update Submitted that Met QC Criteria2024-04-18
Last Update Posted2024-04-23
Last Verified2024-04