Clinical trial NCT06380101: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Primary outcomes:
measure: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
timeFrame: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
Secondary outcomes:
measure: Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema
timeFrame: approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
measure: Absolute and relative change from baseline of circulating non-essential amino acids
timeFrame: from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
measure: Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food
timeFrame: approximately 4 weeks after SCRT with NEAAR medical food intervention
measure: molecular ctDNA response.
timeFrame: approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Richard R Tuli, MD
role: PRINCIPAL_INVESTIGATOR
References: