Using a special medical food with standard treatment for advanced rectal cancer
Prospective, Single Arm IIA Study to Evaluate the Feasibility of a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food in Combination With Total Neoadjuvant Therapy (TNT) for Management of Locally Advanced Rectal Cancer (LARC) NEAAR-LARC
This study is testing a special medical food to see if it helps adults with advanced rectal cancer stick to their treatment plan while they receive standard radiation and chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06380101 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed adenocarcinoma of the rectum at clinical stage II or III, who are eligible for total mesorectal excision.
Not a fit: Patients with serious cachexia, those requiring high protein intake, or those with certain metabolic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with locally advanced rectal cancer by improving their nutritional status and treatment tolerance.
How similar studies have performed: While the specific approach of NEAAR medical food is novel, similar dietary interventions in cancer treatment have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.