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 Florida1 site in 1 country30 target enrollmentSeptember 8, 2023

ConditionsRectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: University of South Florida
Enrollment: 30
Locations: 1
Primary Endpoint: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 8, 2023

End Date

June 1, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of South Florida

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Secondary Outcomes

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)