A Phase 1/2 interventional study of Methylprednisolone and Prednisone in Cranial Nerve Disorder, Head and Neck Carcinoma and Oropharyngeal Carcinoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Supportive care
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.
PRIMARY OBJECTIVE:
I. To establish feasibility and maximum tolerated dose (MTD) of steroid therapy that provides symptomatic improvement in oropharyngeal cancer (OPC) survivors with late lower cranial neuropathy (LCNP).
SECONDARY OBJECTIVE:
I. To examine endpoints that may be sensitive to functional or symptomatic gains with steroid therapy for late LCNP in OPC survivors by characterizing changes in symptoms, functional status, quality of life (QOL), neurophysiology, and imaging studies after steroid therapy.
TERTIARY OBJECTIVE:
I. To establish a hypothesis-generating database of physiologic, functional, and patient-reported outcomes (PROs) among head and neck cancer (HNC) survivors with late lower cranial neuropathy treated with steroid therapy.
OUTLINE: This is a phase I, dose-escalation study of steroid therapy followed by a phase II study.
Patients receive prednisone orally (PO) (or by feeding tube) once daily (QD) on days 1-5 and then taper off over 2 weeks or methylprednisolone intravenously (IV) over 1 hour on days 1-5 in the absence of disease progression or unacceptable toxicity.
373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.
This study's planned enrollment of 35 is below the median of 48 across 284 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Methylprednisolone · Drug: Prednisone · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Given IV
Also known as: Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone, Firmacort, Medlone 21, Medrate, Medrol, Medrol Veriderm, Medrone, Mega-Star, Meprolone, Methylprednisolonum, Metilbetasone Solubile, Metrocort, Metypresol, Metysolon, Predni-M-Tablinen, Prednilen, Radilem, Sieropresol, Solpredone, Summicort, Urbason, Veriderm Medrol, Wyacort
Given PO
Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Maximum tolerated dose
Time frame: Up to 3 weeks
Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean
Time frame: Baseline up to 3 weeks
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).
Time frame: Up to 3 years
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).
Time frame: Up to 3 years
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).
Time frame: Baseline up to 3 years
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).
Time frame: Baseline up to 3 years
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Cranial Nerve Diseases
M.D. Anderson Cancer Center