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)
Interventionnel
Phase non listée
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.
Catégorie de traitement
Autres
Mutations requises
Aucun
Essai commencé
2023-09-08
Dernière mise à jour par le sponsor
2024-04-23
Achèvement estimé
2024-12-01
Éligibilité
Critères d'inclusion
* 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
Critères d'exclusion
* 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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Détails de la conception
AllocationN/A
Modèle d'interventionSingle Group Assignment
MasquageNone (Open Label)
Nombre à inscrire30
Bras et interventions
Bras
Interventions
Type : Experimental
Description : This is a single arm study in which all subjects will receive NEAAR medical food.
Interventions :
NEAAR Medical Food
Mesures des résultats
Mesures des résultats primaires
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
Mesures des résultats secondaires
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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