Clinical trial · Interventional
High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II trial studies the side effect and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cranial Nerve Disorder | — | UNRESOLVED | — |
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oropharyngeal Carcinoma | Oropharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylprednisolone | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (steroid therapy)
- description
- Patients receive prednisone PO (or by feeding tube) QD on days 1-5 and then taper off over 2 weeks or methylprednisolone IV over 1 hour on days 1-5 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Methylprednisolone
- Drug: Prednisone
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- Up to 3 weeks
- measure
- Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean
- timeFrame
- Baseline up to 3 weeks
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Zayne A S Belal, Christine B Peterson, Carly E Barbon et al. · Int J Radiat Oncol Biol Phys · Sep 24, 2026 · PMID 42782239 pubmed