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NCT Number: NCT06380101

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33606, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEAAR Medical Food

Other

Standardized non-essential amino acid restricted medical food.

Primary outcomes

  1. Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea

    Time frame: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Secondary outcomes

  1. Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema

    Time frame: approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention

  2. Absolute and relative change from baseline of circulating non-essential amino acids

    Time frame: from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention

  3. Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food

    Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention

  4. molecular ctDNA response.

    Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Acronym: NEAAR-LARC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 23, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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