NCT06380101

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
OTHER	NEAAR Medical Food	Standardized non-essential amino acid restricted medical food.

Timeline

• Start date: 2023-09-08
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-04-23
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States