Recruiting
Phase 1
Phase 2

Steroid Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04151082

Conditions

Cranial Nerve Disorder

Head and Neck Carcinoma

Oropharyngeal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

Prednisone

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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.

Conditions

Cranial Nerve Disorder

Head and Neck Carcinoma

Oropharyngeal Carcinoma

Study ID

NCT04151082

Start date

Oct 16, 2019

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Methylprednisolone

Given IV

Prednisone

Given PO

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Katherine A Hutcheson, BA,MS,PHD

713-792-6513karnold@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Katherine A. Hutcheson, BA,MS,PHD

713-792-6920karnold@mdanderson.org

Principal Investigator:

Katherine A. Hutcheson, BA,MS,PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-26.