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

Interventional

Phase not listed

University of South Florida

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.

Treatment Category

Other

Required Mutations

None

Trial Started

2023-09-08

Last Updated by Sponsor

2024-04-23

Estimated Completion

2024-12-01

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

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll30

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: This is a single arm study in which all subjects will receive NEAAR medical food.

Interventions:

NEAAR Medical Food

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schemaapproximately 8 weeks after SCRT-TNT with NEAAR medical food intervention

Absolute and relative change from baseline of circulating non-essential amino acidsfrom baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention

Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical foodapproximately 4 weeks after SCRT 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.