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
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.
Categoria di Trattamento
Altri
Mutazioni richieste
Nessuno
Studio Iniziato
2023-09-08
Ultimo Aggiornamento dello Sponsor
2024-04-23
Completamento Stimato
2024-12-01
Idoneità
Criteri di Inclusione
* 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.
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