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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonessential Amino Acid Restriction (NEAAR) Medical Food | Experimental | This is a single arm study in which all subjects will receive NEAAR medical food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEAAR Medical Food | Other | Standardized non-essential amino acid restricted medical food. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard R Tuli, MD | Contact | 813 844 7585 | rtuli@usf.edu | |
| Keira O'Connor | Contact | 813 844 8486 | keiraoconnor@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard R Tuli, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |