RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-09-08
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06380101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed diagnosis of adenocarcinoma of the rectum
  2. * Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI
  3. * Eligible for total mesorectal excision
  4. * No evidence of distant metastasis
  5. * No prior pelvic radiation therapy
  6. * No prior chemotherapy
  7. * Age ≥18 years
  1. * Patients unable to undergo MRI
  2. * Other anticancer or experimental therapy
  3. * Body mass index (BMI) \<18.5 kg/m2 or \>40 kg/m2
  4. * Serious or refractive cachexia or anorexia
  5. * 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

Contacts and Locations

Study Contact

Jennifer Burgess, MS
CONTACT
434-806-6445
jburgess@tgh.org
Veronique Perry, MHSA
CONTACT
2549873658
vperry@tgh.org

Principal Investigator

Richard R Tuli, MD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

University of South Florida
Tampa, Florida, 33606
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Richard R Tuli, MD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-08
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-09-08
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Rectal Cancer