NCT04151082 High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors
| NCT ID | NCT04151082 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Cranial Nerve Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2019-10-16 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2019-10-16 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Katherine A Hutcheson, BA,MS,PHD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04151082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cranial Nerve Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04151082 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04151082 currently recruiting?
Yes, NCT04151082 is actively recruiting participants. Contact the research team at karnold@mdanderson.org for enrollment information.
Where is the NCT04151082 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04151082 clinical trial?
NCT04151082 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Katherine A Hutcheson, BA,MS,PHD at M.D. Anderson Cancer Center. The trial plans to enroll 35 participants.