Recruiting

NEAAR with Total Neoadjuvant Therapy

Sponsor:

University of South Florida

Code:

NCT06380101

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NEAAR Medical Food

Study Details

Brief 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.

Conditions

Rectal Cancer

Study ID

NCT06380101

Start date

Sep 8, 2023

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Nonessential Amino Acid Restriction (NEAAR) Medical Food

This is a single arm study in which all subjects will receive NEAAR medical food.

Interventions

NEAAR Medical Food

Standardized non-essential amino acid restricted medical food.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Richard R Tuli, MD

813 844 7585rtuli@usf.edu

Keira O'Connor

813 844 8486keiraoconnor@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Jennifer Burgess, MS

434-806-6445jburgess@tgh.org

Veronique Perry, MSHA

2549873658vperry@tgh.org

Principal Investigator:

Richard Tuli, MD

More Information

Sponsor

University of South Florida

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-12-10.