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

Primary Purpose

Cranial Nerve Disorder, Head and Neck Carcinoma, Oropharyngeal Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Methylprednisolone

Prednisone

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Cranial Nerve Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (steroid therapy)

Arm 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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose

Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean

Secondary Outcome Measures

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).

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).

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).

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).

Full Information

NCT ID

NCT04151082

First Posted

October 16, 2019

Last Updated

August 22, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04151082

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 31, 2019 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cranial Nerve Disorder, Head and Neck Carcinoma, Oropharyngeal Carcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (steroid therapy)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Other Intervention Name(s)

Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone, Firmacort, Medlone 21, Medrate, Medrol, Medrol Veriderm, Medrone, Mega-Star, Meprolone, Methylprednisolonum, Metilbetasone Solubile, Metrocort, Metypresol, Metysolon, Predni-M-Tablinen, Prednilen, Radilem, Sieropresol, Solpredone, Summicort, Urbason, Veriderm Medrol, Wyacort

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

.delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Maximum tolerated dose

Time Frame

Up to 3 weeks

Title

Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean

Time Frame

Baseline up to 3 weeks

Secondary Outcome Measure Information:

Title

Improvement in tongue innervation on electromyography (EMG) findings

Description

Time Frame

Up to 3 years

Title

Improvement in dynamic imaging grade of swallowing toxicity (DIGEST) scores

Description

1. DIGEST scores are rated on a 0-4 scale from 0 (best) to 4 (worst).

Time Frame

Up to 3 years

Title

Changes in maximum isometric lingual strength (MILS) and lingual range of motion (LROM)

Description

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).

Time Frame

Baseline up to 3 years

Title

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)

Description

Time Frame

Baseline up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katherine A Hutcheson

Phone

713-792-6513

karnold@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine A Hutcheson

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katherine A. Hutcheson

Phone

713-792-6920

karnold@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Katherine A. Hutcheson

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center Website

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

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