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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06735 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0207 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (steroid therapy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | Up to 3 weeks | |
| Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean | Baseline up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in tongue innervation on electromyography (EMG) findings |
| Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine A Hutcheson, BA,MS,PHD | Contact | 713-792-6513 | karnold@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Katherine A Hutcheson, BA,MS,PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Prednisone | Drug | Given PO |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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). | Up to 3 years |
| Changes in maximum isometric lingual strength (MILS) and lingual range of motion (LROM) |
| 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) |
| Baseline up to 3 years |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| C052932 | exifone |
| C011906 | Medrol Veriderm |
| D011241 | Prednisone |
| C407664 | deltacortene |
| C036266 | prednylidene |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
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