Cranial Nerve Disorder, Head and Neck Carcinoma, Oropharyngeal Carcinoma
Conditions
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: 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.
Interventions
DRUGMethylprednisolone
Given IV
DRUGPrednisone
Given PO
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
*
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in tongue innervation on electromyography (EMG) findings | Up to 3 years | 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 | Up to 3 years | 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) | Baseline up to 3 years | 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) | Baseline up to 3 years | 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). |
Countries
United States
Contacts
CONTACTKatherine A Hutcheson, BA,MS,PHD
PRINCIPAL_INVESTIGATORKatherine A Hutcheson, BA,MS,PHD
M.D. Anderson Cancer Center
Outcome results
None listed