NCT06380101 Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
| NCT ID | NCT06380101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-09-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-09-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Richard R Tuli, MD
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT06380101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06380101 currently recruiting?
Yes, NCT06380101 is actively recruiting participants. Contact the research team at rtuli@usf.edu for enrollment information.
Where is the NCT06380101 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT06380101 clinical trial?
NCT06380101 is sponsored by University of South Florida. The principal investigator is Richard R Tuli, MD at University of South Florida. The trial plans to enroll 30 participants.
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