[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374101":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":111,"centralContacts":115,"locations":120,"responsibleParty":140,"collaborators":142,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":110,"eligibilityCriteria":152,"healthyVolunteers":148,"sex":153,"minAge":154,"maxAge":110,"enrollmentInfo":155,"targetDuration":110,"studyType":158,"phases":159,"briefSummary":162,"conditions":163,"keywords":110,"overallStatus":123,"whyStopped":110,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive care (steroid therapy)","EXPERIMENTAL","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.",[13,14,15,16],"Drug: Methylprednisolone","Drug: Prednisone","Other: Quality-of-Life Assessment","Other: Questionnaire Administration",[18,54,101,107],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Methylprednisolone","Given IV",[9],[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Adlone","Caberdelta M","DepMedalone","Depo Moderin","Depo-Nisolone","Duralone","Emmetipi","Esametone","Firmacort","Medlone 21","Medrate","Medrol","Medrol Veriderm","Medrone","Mega-Star","Meprolone","Methylprednisolonum","Metilbetasone Solubile","Metrocort","Metypresol","Metysolon","Predni-M-Tablinen","Prednilen","Radilem","Sieropresol","Solpredone","Summicort","Urbason","Veriderm Medrol","Wyacort",{"type":19,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Prednisone","Given PO",[9],[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],".delta.1-Cortisone","1, 2-Dehydrocortisone","Adasone","Cortancyl","Dacortin","DeCortin","Decortisyl","Decorton","Delta 1-Cortisone","Delta-Dome","Deltacortene","Deltacortisone","Deltadehydrocortisone","Deltasone","Deltison","Deltra","Econosone","Lisacort","Meprosona-F","Metacortandracin","Meticorten","Ofisolona","Orasone","Panafcort","Panasol-S","Paracort","Perrigo Prednisone","PRED","Predicor","Predicorten","Prednicen-M","Prednicort","Prednidib","Prednilonga","Predniment","Prednisone Intensol","Prednisonum","Prednitone","Promifen","Rayos","Servisone","SK-Prednisone",{"type":6,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"Quality-of-Life Assessment","Ancillary studies",[9],[106],"Quality of Life Assessment",{"type":6,"name":108,"description":103,"armGroupLabels":109,"otherNames":110},"Questionnaire Administration",[9],null,[112],{"name":113,"affiliation":5,"role":114},"Katherine A Hutcheson, BA,MS,PHD","PRINCIPAL_INVESTIGATOR",[116],{"name":113,"role":117,"phone":118,"phoneExt":110,"email":119},"CONTACT","713-792-6513","karnold@mdanderson.org",[121],{"facility":122,"status":123,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":135},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":130,"coordinates":131},"Point",[132,133],-95.36327,29.76328,{"lat":133,"lon":132},[136,139],{"name":137,"role":117,"phone":138,"phoneExt":110,"email":119},"Katherine A. Hutcheson, BA,MS,PHD","713-792-6920",{"name":137,"role":114,"phone":110,"phoneExt":110,"email":110},{"type":141,"investigatorFullName":110,"investigatorTitle":110,"investigatorAffiliation":110,"oldNameTitle":110,"oldOrganization":110},"SPONSOR",[143],{"name":144,"class":145},"National Cancer Institute (NCI)","NIH","100374101","phase-1-high-dose-steroid-therapy-prednisone-or-methylprednisolone-for-the-improvement-of-symptoms-of-late-radiation-associated-lower-cranial-neuropathy-in-oropharyngeal-cancer-survivors-100374101",false,"NCT04151082","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\u002FII Dose Finding Trial and Data Registry","Inclusion Criteria:\n\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Treated with radiotherapy \\>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* 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\u002For biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy\n* 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\n* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer\n* INCLUSION CRITERIA FOR REGISTRY: \\>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* 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\u002For biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\n\nExclusion Criteria:\n\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic \\> 160; diastolic \\> 90)\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known history or diagnosis of bipolar disorder\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of surgery near hypoglossal nerve path\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled hypertension (systolic \\> 160; diastolic \\> 90)\n* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis\n* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women\n* EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR REGISTRY: Known history or diagnosis of bipolar disorder","ALL","18 Years",{"count":156,"type":157},35,"ESTIMATED","INTERVENTIONAL",[160,161],"PHASE1","PHASE2","This phase I\u002FII 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.",[164,165,166],"Cranial Nerve Disorder","Head and Neck Carcinoma","Oropharyngeal Carcinoma","2026-06-24",{"date":169,"type":170},"2026-06-26","ACTUAL",{"date":172,"type":170},"2019-10-16",{"date":174,"type":157},"2027-07-31",{"name":5,"class":6},1]