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Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) - Trial NCT06380101

Access comprehensive clinical trial information for NCT06380101 through Pure Global AI's free database. This phase not specified trial is sponsored by University of South Florida and is currently Recruiting. The study focuses on Rectal Cancer. Target enrollment is 30 participants.

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NCT06380101
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Trial Details
ClinicalTrials.gov โ€ข NCT06380101
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Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
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

Study Focus

Rectal Cancer

NEAAR Medical Food

Interventional

other

Sponsor & Location

University of South Florida

Tampa, United States of America

Timeline & Enrollment

N/A

Sep 08, 2023

Jun 01, 2025

30 participants

Primary Outcome

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

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.

ICD-10 Classifications

Malignant neoplasm of rectum
Carcinoma in situ: Rectum
Benign neoplasm: Rectum
Secondary malignant neoplasm of large intestine and rectum
Carcinoma in situ: Rectosigmoid junction

Data Source

ClinicalTrials.gov

NCT06380101

Non-Device Trial