High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Head and Neck Carcinoma; Cranial Nerve Disorder; Oropharyngeal Carcinoma

Treatments: Other: Questionnaire Administration; Drug: Prednisone; Other: Quality-of-Life Assessment; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04151082

NCI-2019-06735 (Registry Identifier)

2019-0207 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Supportive care (steroid therapy)

Experimental group

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.

Treatment:

Drug: Methylprednisolone

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Drug: Prednisone