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Evaluating NEAAR Medical Food for Locally Advanced Rectal Cancer

This study is looking at a special food called NEAAR Medical Food for adults with locally advanced rectal cancer. It's being tested alongside standard treatments like radiation and chemotherapy. The main goal is to see if it's safe and if people can stick with it, especially checking for severe diarrhea. You might be able to join if you have a specific type of rectal cancer that hasn't spread far, are eligible for surgery, and haven't had prior radiation or chemotherapy. The study is currently unclear on its recruitment status and plans to enroll about 30 people.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for diarrhea is measured up to approximately 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06380101

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

Recruiting
NAAges 18+Interventional
University of South Florida
~30 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:NEAAR Medical Food

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
Measured over During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year

Conditions

Rectal Cancer

Explore related trials

Rectal Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

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

Who to contact

Richard R Tuli, MD
[email protected]
813 844 7585
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrheaDuring standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year