Rectal Cancer
Conditions
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.
Interventions
OTHERNEAAR Medical Food
Standardized non-essential amino acid restricted medical food.
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food | approximately 4 weeks after SCRT with NEAAR medical food intervention |
| molecular ctDNA response. | approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention. |
Countries
United States
Contacts
Primary ContactRichard R Tuli, MD
Backup ContactKeira O'Connor
Outcome results
None listed