Actively Recruiting
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
Led by University of South Florida · Updated on 2025-12-10
30
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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�ae)
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
Research Team
R
Richard R Tuli, MD
CONTACT
K
Keira O'Connor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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