To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
NCT ID:
NCT06380101
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
NEAAR Medical Food
Description:
Standardized non-essential amino acid restricted medical food.
Arm group label:
Nonessential Amino Acid Restriction (NEAAR) Medical Food
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of South Florida
Address:
City:
Tampa
Zip:
33606
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Burgess, MS
Phone:
434-806-6445
Email:
jburgess@tgh.org
Contact backup:
Last name:
Veronique Perry, MSHA
Phone:
2549873658
Email:
vperry@tgh.org
Investigator:
Last name:
Richard Tuli, MD
Email:
Principal Investigator
Start date:
September 8, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
University of South Florida
Agency class:
Other
Source:
University of South Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06380101
