NCT06380101

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Sep 2023Jun 2027

Study Start

First participant enrolled

September 8, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

April 18, 2024

Last Update Submit

December 3, 2025

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

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

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

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

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

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

    approximately 4 weeks after SCRT with NEAAR medical food intervention

  • molecular ctDNA response.

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

Study Arms (1)

Nonessential Amino Acid Restriction (NEAAR) Medical Food

EXPERIMENTAL

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

Other: NEAAR Medical Food

Interventions

NEAAR Medical FoodOTHER

Standardized non-essential amino acid restricted medical food.

Nonessential Amino Acid Restriction (NEAAR) Medical Food

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Richard R Tuli, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard R Tuli, MD

CONTACT

813 844 7585rtuli@usf.edu

Keira O'Connor

CONTACT

813 844 8486keiraoconnor@usf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

September 8, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations

US(1)