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NCT04151082 · M.D. Anderson Cancer Center

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

What this study is about

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.

View original scientific description

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.

Interventions

DRUG

Methylprednisolone

Given IV

DRUG

Prednisone

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Primary outcome measures

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • Houston, Texas

Collaborators

National Cancer Institute (NCI)

Related conditions & keywords

Cranial Nerve DisorderHead and Neck CarcinomaOropharyngeal Carcinoma

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations

📊
1 of 35 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

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RECRUITING

Houston

Texas

Location available

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Cranial Nerve Disorder Treatment in Houston?

Join others in Texas exploring innovative treatment options through clinical research

Cranial Nerve Disorder Treatment Options in Houston, Texas

If you're searching for Cranial Nerve Disorder treatment in Houston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Houston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Cranial Nerve Disorder. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Texas
Now Enrolling
Up to 35 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Cranial Nerve Disorder?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Cranial Nerve Disorder

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Cranial Nerve Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04151082. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.