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

University of South Florida

Status

Enrolling

Conditions

Rectal Cancer

Treatments

Other: NEAAR Medical Food

Study type

Interventional

Funder types

Other

Identifiers

NCT06380101

NEAAR-LARC

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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