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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of South Florida

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NEAAR Medical Food

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators