drugset / Trial / NCT07832266

Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT)

NCT07832266 ↗

Phase 1 Not yet recruiting 48 enrolled M.D. Anderson Cancer Center
RandomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn about possible intervention strategies to help control cranial neuropathy in patients after they receive radiation therapy for OPC. Four (4) strategies will be tested in this study: 1) high-dose corticosteroid therapy, 2) treatment with fremanezumab, 3) manual tongue exercise therapy, and 4) device-assisted tongue exercise therapy.

Timeline

Start
2027-03-01
Primary completion
2030-09-30
Completion
2032-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fremanezumab Monoclonal antibody 675 mg Other
Subject Prednisone Other / unclassified 3 mg/kg Oral