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New treatment option for Cranial Nerve Disorder
Official title High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors
ClinicalTrials.gov ID: NCT04151082
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for cranial nerve disorder.
Also referred to as Adlone, Caberdelta M.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer
- FOR CLINICAL TRIAL: Treated with radiotherapy \>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)
- FOR CLINICAL TRIAL: Late radiation-associated lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related...
- FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy
- FOR CLINICAL TRIAL: Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck [MDASI-HN]) in validated languages: English...
You likely can't join if
- 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
See the full eligibility criteria
- FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer
- FOR CLINICAL TRIAL: Treated with radiotherapy \>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)
- 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...
- FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy
- 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...
- FOR REGISTRY: Disease-free adult survivors of head and neck cancer
- FOR REGISTRY: \>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)
- 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...
- FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.