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)
Interventistico
Fase non elencata
University of South Florida
Ultimo Aggiornamento: 10 dicembre 2025 Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.
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
Criteri di Esclusione
* 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
Pensi che questo studio appaia erroneamente?
Dettagli del Disegno
AllocazioneN/A
Modello di InterventoSingle Group Assignment
MascheramentoNone (Open Label)
Numero da Arruolare30
Bracci e Interventi
Bracci
Interventi
Tipo: Experimental
Descrizione: This is a single arm study in which all subjects will receive NEAAR medical food.
Interventi:
NEAAR Medical Food
Misure di Esito
Misure di Esito Primarie
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
Misure di Esito Secondarie
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.