High Dose Steroid Treatment to Improve Symptoms of Late Radiation-Related Lower Cranial Nerve Damage in Oropharyngeal Cancer Survivors Phase III Study to Find Best Dose and Track Outcomes

What this Trial Is About

This trial studies adult survivors of oropharyngeal cancer who have late radiation-associated lower cranial neuropathy, a condition affecting nerves in the head and neck area after radiation treatment. The purpose is to find the best dose and assess the side effects of steroid therapy using prednisone or methylprednisolone to improve symptoms related to this nerve damage. The study includes both a phase I dose-escalation portion and a phase II evaluation. Participants will receive steroid therapy either as oral prednisone once daily for five days followed by a two-week taper, or intravenous methylprednisolone over an hour daily for five days. Treatment continues unless there is disease progression or unacceptable side effects. The study also includes data collection through quality-of-life assessments and questionnaires. During the study, participants will be monitored for safety and the effect of steroids on their symptoms using clinical evaluations, neurophysiological tests like electromyography, and imaging studies. Researchers will assess changes in symptom severity, swallowing function, tongue strength, and patient-reported outcomes over up to three years. The primary focus is determining the maximum tolerated dose and symptom improvement within three weeks of treatment.

High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors