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.
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
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
Single group
Methylprednisolone
DrugGiven IV
Prednisone
DrugGiven PO
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Maximum tolerated dose
Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean
Improvement in tongue innervation on electromyography (EMG) findings
1. EMG scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'. 2. Nerve conduction study (NCS) scores are based on a 4-point scale ranging from 'none' (best) to 'severely prolonged' or 'severely reduced' (worst).
Improvement in dynamic imaging grade of swallowing toxicity (DIGEST) scores
1\. DIGEST scores are rated on a 0-4 scale from 0 (best) to 4 (worst).
Changes in maximum isometric lingual strength (MILS) and lingual range of motion (LROM)
1. MILS scores are rated on continuous scale from 0 (worst) to 100 (best). 2. LROM scores are rated on an ordinal scale from 0 (worst) to 100 (best).
Changes in patient reported outcomes (PRO) on MD Anderson Dysphagia Inventory (MDADI), Performance Status Scale for Head and Neck (PSS-HN), or EuroQOL (EQ-5D)
1. MDADI scores are rated on a continuous scale from 20 (worst) to 100 (best). 2. Diet, eating, and speech subscales of PSS-HN are rated on an ordinal scale from 0 (worst) to 100 (best). 3. EQ-5D is rated on a continuous scale from 0 (worst) to 100 (best).
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
