High-dose steroid therapy for late lower cranial neuropathy in oropharyngeal cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase I/II interventional trial that uses a dose-escalation approach to determine the maximum tolerated dose and feasibility of steroid therapy for late LCNP in OPC survivors. Participants receive a short course of prednisone or methylprednisolone, with a taper over two weeks, and are monitored for safety and symptom changes. Secondary assessments look at functional status, quality of life, neurophysiology, and imaging to see if steroid therapy yields meaningful improvements. The study aims to generate a database of outcomes to inform future research in head and neck cancer survivors with late radiation-related neuropathy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer
* INCLUSION CRITERIA FOR CLINICAL TRIAL: Treated with radiotherapy \>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)
* INCLUSION CRITERIA FOR CLINICAL TRIAL: Late radiation-associated lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source)
* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy
* INCLUSION CRITERIA FOR CLINICAL TRIAL: Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck \[MDASI-HN\]) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese
* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer
* INCLUSION CRITERIA FOR REGISTRY: \>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)
* INCLUSION CRITERIA FOR REGISTRY: Late lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and/or biopsy fail to demonstrate structural or malignant source)
* INCLUSION CRITERIA FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese

Exclusion Criteria:

* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic \> 160; diastolic \> 90)
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known history or diagnosis of bipolar disorder
* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of surgery near hypoglossal nerve path
* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes
* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled hypertension (systolic \> 160; diastolic \> 90)
* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer
* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis
* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women
* EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture
* EXCLUSION CRITERIA FOR REGISTRY: Known history or diagnosis of bipolar disorder

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Katherine A Hutcheson, BA,MS,PHD — M.D. Anderson Cancer Center
• Study coordinator: Katherine A Hutcheson, BA,MS,PHD
• Email: karnold@mdanderson.org
• Phone: 713-792-6513

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.