[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04151082":3,"trial-entities:NCT04151082":186,"trial-summary:NCT04151082":189},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":125,"secondary_outcomes":132,"sex":147,"minimum_age":148,"maximum_age":149,"healthy_volunteers":15,"eligibility_criteria":150,"std_ages":154,"locations":157,"central_contacts":175,"overall_officials":179,"references":181,"see_also_links":182},"NCT04151082","2019-0207","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","RECRUITING","2027-07-31","2026-06","2026-06-26","2019-10-16","M.D. Anderson Cancer Center","OTHER",false,"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.","PRIMARY OBJECTIVE:\n\nI. To establish feasibility and maximum tolerated dose (MTD) of steroid therapy that provides symptomatic improvement in oropharyngeal cancer (OPC) survivors with late lower cranial neuropathy (LCNP).\n\nSECONDARY OBJECTIVE:\n\nI. To examine endpoints that may be sensitive to functional or symptomatic gains with steroid therapy for late LCNP in OPC survivors by characterizing changes in symptoms, functional status, quality of life (QOL), neurophysiology, and imaging studies after steroid therapy.\n\nTERTIARY OBJECTIVE:\n\nI. To establish a hypothesis-generating database of physiologic, functional, and patient-reported outcomes (PROs) among head and neck cancer (HNC) survivors with late lower cranial neuropathy treated with steroid therapy.\n\nOUTLINE: This is a phase I, dose-escalation study of steroid therapy followed by a phase II study.\n\nPatients receive prednisone orally (PO) (or by feeding tube) once daily (QD) on days 1-5 and then taper off over 2 weeks or methylprednisolone intravenously (IV) over 1 hour on days 1-5 in the absence of disease progression or unacceptable toxicity.",[19,20,21],"Cranial Nerve Disorder","Head and Neck Carcinoma","Oropharyngeal Carcinoma",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[26,27],"PHASE1","PHASE2",{"count":29,"type":30},35,"ESTIMATED",[32,69,116,122],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Methylprednisolone","Given IV",[37],"Supportive care (steroid therapy)",[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68],"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":33,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Prednisone","Given PO",[37],[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],".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":14,"name":117,"description":118,"armGroupLabels":119,"otherNames":120},"Quality-of-Life Assessment","Ancillary studies",[37],[121],"Quality of Life Assessment",{"type":14,"name":123,"description":118,"armGroupLabels":124},"Questionnaire Administration",[37],[126,129],{"measure":127,"timeFrame":128},"Maximum tolerated dose","Up to 3 weeks",{"measure":130,"timeFrame":131},"Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean","Baseline up to 3 weeks",[133,137,140,144],{"measure":134,"description":135,"timeFrame":136},"Improvement in tongue innervation on electromyography (EMG) findings","1. EMG scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'.\n2. Nerve conduction study (NCS) scores are based on a 4-point scale ranging from 'none' (best) to 'severely prolonged' or 'severely reduced' (worst).","Up to 3 years",{"measure":138,"description":139,"timeFrame":136},"Improvement in dynamic imaging grade of swallowing toxicity (DIGEST) scores","1\\. DIGEST scores are rated on a 0-4 scale from 0 (best) to 4 (worst).",{"measure":141,"description":142,"timeFrame":143},"Changes in maximum isometric lingual strength (MILS) and lingual range of motion (LROM)","1. MILS scores are rated on continuous scale from 0 (worst) to 100 (best).\n2. LROM scores are rated on an ordinal scale from 0 (worst) to 100 (best).","Baseline up to 3 years",{"measure":145,"description":146,"timeFrame":143},"Changes in patient reported outcomes (PRO) on MD Anderson Dysphagia Inventory (MDADI), Performance Status Scale for Head and Neck (PSS-HN), or EuroQOL (EQ-5D)","1. MDADI scores are rated on a continuous scale from 20 (worst) to 100 (best).\n2. Diet, eating, and speech subscales of PSS-HN are rated on an ordinal scale from 0 (worst) to 100 (best).\n3. EQ-5D is rated on a continuous scale from 0 (worst) to 100 (best).","ALL","18 Years",null,{"inclusion":151,"exclusion":152,"raw_text":153},[],[],"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",[155,156],"ADULT","OLDER_ADULT",[158],{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":163,"contacts":164,"geoPoint":172},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[165,170],{"name":166,"role":167,"phone":168,"email":169},"Katherine A. Hutcheson, BA,MS,PHD","CONTACT","713-792-6920","karnold@mdanderson.org",{"name":166,"role":171},"PRINCIPAL_INVESTIGATOR",{"lat":173,"lon":174},29.76328,-95.36327,[176],{"name":177,"role":167,"phone":178,"email":169},"Katherine A Hutcheson, BA,MS,PHD","713-792-6513",[180],{"name":177,"affiliation":13,"role":171},[],[183],{"label":184,"url":185},"MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":187,"biomarkers":188},[19,20,21],[],{"nct_id":4,"found":190,"summary":191,"prompt_version":201},true,{"design":192,"status":193,"heading":194,"summary":195,"follow_up":196,"word_count":197,"commitments":198,"compensation":199,"drugs_mentioned":200},"This is a phase I\u002FII study, starting with a dose-escalation phase, and plans to enroll about 35 participants.","completed","Steroid Therapy for Radiation-Associated Cranial Neuropathy","This study is for adult survivors of oropharyngeal (throat) cancer who have developed late radiation-associated lower cranial neuropathy (nerve damage) at least two years after their radiation treatment. It's testing how well and safely steroid medications, prednisone (taken by mouth) or methylprednisolone (given intravenously), can improve symptoms of this nerve damage. Researchers want to find the best dose of these steroids that helps with symptoms. They will also look at how these treatments affect your symptoms, daily function, and quality of life. The study is currently unclear on its recruitment status and plans to enroll about 35 participants.","The primary endpoints are measured up to 3 weeks after starting treatment.",98,"Participants will receive prednisone orally or methylprednisolone intravenously for 5 days, followed by a taper for prednisone over 2 weeks. You will also complete quality-of-life assessments and questionnaires.","Not stated in the trial record.",[34,70],"v2"]