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NCT06380101Recruiting

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
University of South FloridaClinicalTrials.govother
Verified
Study focus
Disease/Condition
Rectal Cancer
Drug/Device/Intervention
NEAAR Medical Food
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of South Florida
Location
Tampa, United States of America
Timeline & enrollment
Phase
N/A
Start date
Sep 08, 2023
End date
Jun 01, 2025
Enrollment
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 rectumCarcinoma in situ: RectumBenign neoplasm: RectumSecondary malignant neoplasm of large intestine and rectumCarcinoma in situ: Rectosigmoid junction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06380101
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.