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 Florida
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.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 nu…
Interventions
- OtherNEAAR Medical Food
Standardized non-essential amino acid restricted medical food.
Location
- University of South FloridaTampa, Florida