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

Last updated: April 18, 2024
Sponsor: University of South Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Colorectal Cancer

Colon Cancer

Treatment

NEAAR Medical Food

Clinical Study ID

NCT06380101
NEAAR-LARC
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

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

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 acidcontaining nutritional supplements (e.g., Ensure®) Patients with a condition wherehigh-fat or fatty food is contraindicated History of confirmed food allergy Activewound or skin graft that would require a significant increase in protein requirementsfor skin integrity and healing

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: NEAAR Medical Food
Phase:
Study Start date:
September 08, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

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