[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100322673":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":124,"collaborators":31,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":31,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":31,"enrollmentInfo":135,"targetDuration":31,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":44,"whyStopped":31,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Matrix Biomed, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active 1000 mg Tempol Solution","ACTIVE_COMPARATOR","Patients will take 1000 mg of Tempol a day for the duration of radiation treatment (6-8 weeks)",[13],"Drug: Tempol",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Solution","PLACEBO_COMPARATOR","Patients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks)",[19],"Drug: Placebo Solution",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tempol","Investigational product is Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) oral solution. Tempol solution is an orange-colored, aqueous solution containing 7% Tempol along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils.",[9],[27],"4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"The placebo contains the same excipients as the active product plus FD\\&C Yellow #6 for color matching.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Benji Crane","STUDY_DIRECTOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","6264376506","bjcrane@matrixbiomed.com",[42,56,65,75,84,89,99,109,119],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":31},"UCSD","RECRUITING","La Jolla","California","92093","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-117.2742,32.84727,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":46,"zip":59,"country":48,"countryCode":49,"cosmosGeoPoint":60,"geoPoint":64,"contacts":31},"Mercy Medical Center","Merced","95340",{"type":51,"coordinates":61},[62,63],-120.48297,37.30216,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":46,"zip":69,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":31},"UCSF Helen Diller Family Comprehensive Cancer Center","ACTIVE_NOT_RECRUITING","San Francisco","94158",{"type":51,"coordinates":71},[72,73],-122.41942,37.77493,{"lat":73,"lon":72},{"facility":76,"status":44,"city":77,"state":46,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":31},"Central Coast Medical Oncology","Santa Maria","93454",{"type":51,"coordinates":80},[81,82],-120.43572,34.95303,{"lat":82,"lon":81},{"facility":85,"status":44,"city":77,"state":46,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":86,"geoPoint":88,"contacts":31},"Mission Hope Health Center",{"type":51,"coordinates":87},[81,82],{"lat":82,"lon":81},{"facility":90,"status":44,"city":91,"state":92,"zip":93,"country":48,"countryCode":49,"cosmosGeoPoint":94,"geoPoint":98,"contacts":31},"Montefiore Medical Center-Einstein Campus","The Bronx","New York","10461",{"type":51,"coordinates":95},[96,97],-73.86641,40.84985,{"lat":97,"lon":96},{"facility":100,"status":44,"city":101,"state":102,"zip":103,"country":48,"countryCode":49,"cosmosGeoPoint":104,"geoPoint":108,"contacts":31},"Wake Forest University Health Sciences","Winston-Salem","North Carolina","27157",{"type":51,"coordinates":105},[106,107],-80.24422,36.09986,{"lat":107,"lon":106},{"facility":110,"status":44,"city":111,"state":112,"zip":113,"country":48,"countryCode":49,"cosmosGeoPoint":114,"geoPoint":118,"contacts":31},"Seattle Cancer Care Alliance","Seattle","Washington","98195",{"type":51,"coordinates":115},[116,117],-122.33207,47.60621,{"lat":117,"lon":116},{"facility":120,"status":44,"city":111,"state":112,"zip":113,"country":48,"countryCode":49,"cosmosGeoPoint":121,"geoPoint":123,"contacts":31},"University of Washington Medical Center",{"type":51,"coordinates":122},[116,117],{"lat":117,"lon":116},{"type":125,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100322673","phase-2-treatment-of-radiation-and-cisplatin-induced-toxicities-with-tempol-100322673",false,"NCT03480971","Treatment of Radiation and Cisplatin Induced Toxicities with Tempol","A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy","Inclusion Criteria:\n\n1. Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);\n2. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;\n3. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;\n4. If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study;\n5. Must be receiving cisplatin for chemotherapy;\n6. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;\n7. Must have a score 2 or less on the ECOG performance status;\n8. Participant life expectancy ≥ 6 months; and\n9. Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):\n\nHaematology:\n\nAbsolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g\u002FdL Platelets ≥ 100,000 per microliter of blood\n\nHepatic:\n\nTotal bilirubin ≤ 2 X (Upper limit normal) ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ≤5 x ULN\n\nRenal:\n\nSerum creatinine ≤ ULN or, if \\> ULN calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin.\n\nNutritional and metabolic:\n\nUrine Albumin \\\u003C 3.0 mg\u002Fdl\n\nExclusion Criteria:\n\n1. Prior radiotherapy of the head and neck;\n2. Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study treatment;\n3. Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;\n4. Be taking mugard;\n5. Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;\n6. Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;\n7. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;\n8. Have used an investigational drug within 28 days of the initiation of study treatment;\n9. Have a history of a positive blood test for HIV;\n10. At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study;\n11. Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;\n12. Participants with body weight less than 35 kg, 77 lbs;\n13. Women who are pregnant or who are breastfeeding;\n14. Participants with known intolerance to platin drugs;\n15. History of insulin-dependent Diabetes Mellitus; and\n16. Participants with Hepatitis B\u002FC.","ALL","18 Years",{"count":136,"type":137},120,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","A 10 week trial to assess the ability of Tempol to prevent and\u002For reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.",[143,144,145],"Mucositis","Nephrotoxicity","Ototoxicity",[147],"cisplatin toxicity","2024-11-18",{"date":150,"type":151},"2024-11-20","ACTUAL",{"date":153,"type":151},"2019-05-13",{"date":155,"type":137},"2025-12",{"name":5,"class":6},9]