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

Rectal Cancer Clinical Trial

— NEAAR-LARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380101
• Other study ID #: NEAAR-LARC
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of South Florida
• Contact: Jennifer Burgess, MS
• Phone: 434-806-6445
• Email: jburgess[@]tgh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• NEAAR Medical Food
Standardized non-essential amino acid restricted medical food.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food		approximately 4 weeks after SCRT with NEAAR medical food intervention
Secondary	molecular ctDNA response.		approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.