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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06380101
Other study ID # NEAAR-LARC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2023
Est. completion date June 2025

Study information

Verified date April 2024
Source University of South Florida
Contact Jennifer Burgess, MS
Phone 434-806-6445
Email jburgess@tgh.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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., EnsureĀ®) 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NEAAR Medical Food
Standardized non-essential amino acid restricted medical food.

Locations

Country Name City State
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
Secondary Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Secondary Absolute and relative change from baseline of circulating non-essential amino acids from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Secondary Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food approximately 4 weeks after SCRT with NEAAR medical food intervention
Secondary molecular ctDNA response. approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.
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