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

Not Applicable

Recruiting

• Conditions: Rectal Cancer
• Interventions: Other: NEAAR Medical Food

• Registration Number: NCT06380101
• Lead Sponsor: University of South Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nonessential Amino Acid Restriction (NEAAR) Medical Food	NEAAR Medical Food	This is a single arm study in which all subjects will receive NEAAR medical food.

Primary Outcome Measures

Name	Time	Method
Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea	During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Secondary Outcome Measures

Name	Time	Method
Absolute and relative change from baseline of circulating non-essential amino acids	from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
molecular ctDNA response.	approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.
Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema	approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food	approximately 4 weeks after SCRT with NEAAR medical food intervention

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States