Last updated: April 18, 2024
Sponsor: University of South Florida
Overall Status: Active - Recruiting
Phase
N/A
Condition
Rectal Cancer
Colorectal Cancer
Colon Cancer
Treatment
NEAAR Medical Food
Clinical Study ID
NCT06380101
NEAAR-LARC
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 acidcontaining nutritional supplements (e.g., Ensure®) Patients with a condition wherehigh-fat or fatty food is contraindicated History of confirmed food allergy Activewound or skin graft that would require a significant increase in protein requirementsfor skin integrity and healing
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: NEAAR Medical Food
Phase:
Study Start date:
September 08, 2023
Estimated Completion Date:
June 30, 2025
Connect with a study center
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
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