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

Head and Neck Carcinoma Clinical Trial

Official title:

Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151082
• Other study ID #: 2019-0207
• Secondary ID: NCI-2019-0673520
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 31, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Katherine A Hutcheson
• Phone: 713-792-6513
• Email: karnold[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cranial Nerve Diseases
• Cranial Nerve Disorder
• Head and Neck Carcinoma
• Oropharyngeal Carcinoma

Intervention

Drug:
• Methylprednisolone
Given IV
• Prednisone
Given PO

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		Up to 3 weeks
Primary	Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean		Baseline up to 3 weeks
Secondary	Improvement in tongue innervation on electromyography (EMG) findings	EMG scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'.; Nerve conduction study (NCS) scores are based on a 4-point scale ranging from 'none' (best) to 'severely prolonged' or 'severely reduced' (worst).	Up to 3 years
Secondary	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
Secondary	Changes in maximum isometric lingual strength (MILS) and lingual range of motion (LROM)	MILS scores are rated on continuous scale from 0 (worst) to 100 (best).; LROM scores are rated on an ordinal scale from 0 (worst) to 100 (best).	Baseline up to 3 years
Secondary	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)	MDADI scores are rated on a continuous scale from 20 (worst) to 100 (best).; Diet, eating, and speech subscales of PSS-HN are rated on an ordinal scale from 0 (worst) to 100 (best).; EQ-5D is rated on a continuous scale from 0 (worst) to 100 (best).	Baseline up to 3 years

External Links

•   MD Anderson Cancer Center Website