NCT04151082RecruitingPhase 1/2
High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 16 Oct 2019
- Start date
- 16 Oct 2019
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT04151082
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 35
- From 16 Oct 2019 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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: 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: Known history or diagnosis of bipolar disorder
Other
- EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women
- EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture
- EXCLUSION CRITERIA FOR REGISTRY: Pregnant women
- EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.