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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Standardized non-essential amino acid restricted medical food.
University of South Florida
Tampa, Florida, United States
RECRUITINGRate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea
Time frame: During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema
Time frame: approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Absolute and relative change from baseline of circulating non-essential amino acids
Time frame: from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food
Time frame: approximately 4 weeks after SCRT with NEAAR medical food intervention
molecular ctDNA response.
Time frame: 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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