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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

FL