Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
Study Overview
Brief Summary
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.
Detailed 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Supportive care (steroid therapy)
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.
Intervention: Quality-of-Life Assessment (Other)
Supportive care (steroid therapy)
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.
Intervention: Questionnaire Administration (Other)
Supportive care (steroid therapy)
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.
Intervention: Methylprednisolone (Drug)
Supportive care (steroid therapy)
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.
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Improvement in tongue innervation on electromyography (EMG) findings(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)
- Improvement in tongue innervation on electromyography (EMG) findings(Up to 3 years)
- Improvement in dynamic imaging grade of swallowing toxicity (DIGEST) scores(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)