Using a special medical food with standard treatment for advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients diagnosed with locally advanced rectal cancer. Participants will receive this medical food alongside standard short-course radiotherapy followed by chemotherapy. The study aims to determine how well patients can adhere to this dietary intervention while undergoing conventional cancer treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Richard R Tuli, MD — University of South Florida
• Study coordinator: Richard R Tuli, MD
• Email: rtuli@usf.edu
• Phone: 813 844 7585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.