Steroid Therapy for Radiation-Associated Cranial Neuropathy
This study is for adult survivors of oropharyngeal (throat) cancer who have developed late radiation-associated lower cranial neuropathy (nerve damage) at least two years after their radiation treatment. It's testing how well and safely steroid medications, prednisone (taken by mouth) or methylprednisolone (given intravenously), can improve symptoms of this nerve damage. Researchers want to find the best dose of these steroids that helps with symptoms. They will also look at how these treatments affect your symptoms, daily function, and quality of life. The study is currently unclear on its recruitment status and plans to enroll about 35 participants.
- Study design
- This is a phase I/II study, starting with a dose-escalation phase, and plans to enroll about 35 participants.
- What's involved
- Participants will receive prednisone orally or methylprednisolone intravenously for 5 days, followed by a taper for prednisone over 2 weeks. You will also complete quality-of-life assessments and questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured up to 3 weeks after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors
At a glance
Conditions
NCT04151082
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Katherine A Hutcheson, BA,MS,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Maximum tolerated doseUp to 3 weeks
- Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 meanBaseline up to 3 weeks