NEAAR-LARC: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) (NCT06380101)
NEAAR-LARC: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
Interventionsstudie
Phase nicht angegeben
University of South Florida
Zuletzt aktualisiert: 10. Dezember 2025 Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.
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.
* 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
Ausschlusskriterien
* 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
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Design-Details
ZuteilungN/A
InterventionsmodellSingle Group Assignment
MaskierungNone (Open Label)
Anzahl der Teilnehmer30
Arme & Interventionen
Arme
Interventionen
Typ: Experimental
Beschreibung: This is a single arm study in which all subjects will receive NEAAR medical food.
Interventionen:
NEAAR Medical Food
Ergebnismessungen
Primäre Ergebnismessungen
Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrheaDuring standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year
Sekundäre Ergebnismessungen
Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schemaapproximately 8 weeks after SCRT-TNT with NEAAR medical food intervention
Absolute and relative change from baseline of circulating non-essential amino acidsfrom 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 foodapproximately 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.
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