[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570384":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":52,"locations":61,"responsibleParty":80,"collaborators":83,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":56,"enrollmentInfo":109,"targetDuration":56,"studyType":112,"phases":113,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":64,"whyStopped":56,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Dr. Negrin University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ozone Group","EXPERIMENTAL","Drug: Ozone (O3\u002FO2). Treatment: Usual treatment + Ozone therapy by rectal insufflation. O3\u002FO2 concentration progressively increased from 10 to 30 μg\u002Fml; 40 sessions in 16 weeks.",[13],"Drug: Ozone therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Oxygen Group (Placebo)","PLACEBO_COMPARATOR","Drug: Oxygen (O2). Treatment: Usual treatment + Oxygen by rectal insufflation. O3\u002FO2 concentration = 0 μg\u002Fml (only O2); 40 sessions in 16 weeks.",[19],"Drug: Oxygen (placebo)",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ozone therapy","Usual treatment (by their oncologist or hematologist) + Ozone therapy by rectal insufflation. O3\u002FO2 concentration progressively increased from 10 to 30 μg\u002Fml; 40 sessions in 16 weeks.",[9],[27,28,29],"Ozone treatment","O3","O3\u002FO2 gas mixture",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Oxygen (placebo)","Usual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3\u002FO2 concentration = 0 μg\u002Fml (only O2); 40 sessions in 16 weeks.",[15],[35],"O2",[37,41,44,47,50,51],{"name":38,"affiliation":39,"role":40},"Bernardino Clavo, MD, PhD","Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain","STUDY_CHAIR",{"name":42,"affiliation":39,"role":43},"Francisco Rodríguez-Esparragón, BSc, PhD","STUDY_DIRECTOR",{"name":45,"affiliation":39,"role":46},"Himar Fabelo, BSc, PhD","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":49,"role":46},"Gustavo M Callicó, Prof, PhD","Institute for Applied Microelectronics, University of Las Palmas de Gran Canaria, Spain",{"name":42,"affiliation":39,"role":46},{"name":38,"affiliation":39,"role":46},[53,58],{"name":38,"role":54,"phone":55,"phoneExt":56,"email":57},"CONTACT","34928449278",null,"bernardinoclavo@gmail.com",{"name":42,"role":54,"phone":59,"phoneExt":56,"email":60},"34928449288","afrodesp@gmail.com",[62],{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Dr. Negrín University Hospital","RECRUITING","Las Palmas","35019","Spain","ES",{"type":70,"coordinates":71},"Point",[72,73],-16.16555,28.58232,{"lat":73,"lon":72},[76,77,78,79],{"name":38,"role":54,"phone":55,"phoneExt":56,"email":57},{"name":42,"role":54,"phone":59,"phoneExt":56,"email":60},{"name":38,"role":46,"phone":56,"phoneExt":56,"email":56},{"name":42,"role":46,"phone":56,"phoneExt":56,"email":56},{"type":81,"investigatorFullName":38,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"SPONSOR_INVESTIGATOR","Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital",[84,86,88,91,93,95,96],{"name":85,"class":6},"Council of Gran Canaria",{"name":87,"class":6},"Centers for International Business Education and Research",{"name":89,"class":90},"Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)","UNKNOWN",{"name":92,"class":6},"Complejo Hospitalario Universitario Insular Materno Infantil",{"name":94,"class":6},"Servicio Canario de Salud",{"name":49,"class":90},{"name":97,"class":98},"Instituto de Salud Carlos III","OTHER_GOV","100570384","phase-2-ozone-treatment-in-paresthesia-numbness-tingling-secondary-to-chemotherapy-induced-peripheral-neuropathy-100570384",false,"NCT06706544","Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy","Effectiveness and Cost-effectiveness of Ozone Treatment in Patients With Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (OzoParQT)","OzoParQT","Inclusion Criteria:\n\n* 1\\. Adults \\> = 18 years old.\n* 2\\. Previous treatment with any chemotherapy because of any tumor.\n* 3\\. Clinical diagnosis of paresthesia (numbness, tingling) secondary to CIPN, with toxicity Grade \\> = 2 (according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0) for \\> = 3 months.\n* 4\\. Without neurotoxic chemotherapy \\> = 3 months.\n* 5\\. Cancer disease is stable or in remission.\n* 6\\. Life expectancy \\> = 6 months.\n* 7\\. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit and accept the use of appropriate contraceptive methods at least from 14 days before the first ozone therapy session up to 14 days after the last one.\n* 8\\. To sign and date the study-specific informed consent\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years.\n* 2\\. A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods.\n* 3\\. Suspected symptoms are due to diabetic or compressive neuropathy.\n* 4\\. Severe psychiatric disorders.\n* 5\\. Inability to complete the quality of life questionnaires.\n* 6\\. Elevation above 5 times the maximum limit of normal creatinine.\n* 7\\. Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures.\n* 8\\. Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy.\n* 9\\. Life expectancy (for any reason) \\\u003C 6 months.\n* 10\\. Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.\n* 11\\. Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.\n* 12\\. Not meeting each and every one of the inclusion criteria","ALL","18 Years",{"count":110,"type":111},42,"ESTIMATED","INTERVENTIONAL",[114,115],"PHASE2","PHASE3","The goal of this phase II\u002FIII randomized clinical trial is to evaluate the effect of adding rectal ozone therapy to the usual management of patients with paresthesia (numbness and\u002For tingling) due to chemotherapy-induced peripheral neuropathy (CIPN). Ozone treatment consists of the rectal insufflation of 180 - 300 milliliters of an ozone\u002Foxygen gas mixture.\n\nThe main questions to answer are:\n\n1. Can ozone therapy improve patients' self-perceived level of numbness and tingling?\n2. Can ozone therapy improve patients' self-perceived health-related quality of life (HRQoL)?\n\nIn 42 patients with chronic numbness and tingling secondary to chemotherapy, the researchers will compare:\n\n* the addition of rectal ozone insufflations\n* versus the addition of rectal oxygen insufflations (placebo). Participants will receive 40 rectal gas (ozone versus oxygen) insufflations in 16 weeks and will continue other symptomatic or cancer treatments prescribed by their oncologists.\n\nBefore treatment, after treatment, and 12 weeks after treatment, they will be evaluated:\n\n* Several questionnaires about neuropathy, quality of life, and anxiety and depression.\n* Biochemical parameters of oxidative stress and inflammation\n* Hyperspectral images of hands and feet\n* Toxicity of procedure.",[118,119,120,121],"Chemotherapy Induced Peripheral Neuropathy (CIPN)","Paresthesia","Numbness","Tingling",[123,124,125,126,127,128,129,130,131,132,133],"Chemotherapy induced peripheral neuropathy","paresthesia","numbness and tingling","side effect of cancer treatment","toxicity of chemotherapy","ozone therapy","quality of life","anxiety","depression","hyperspectral imaging","oxidative stress","2025-02-07",{"date":136,"type":137},"2025-02-11","ACTUAL",{"date":134,"type":137},{"date":140,"type":111},"2030-03-31",{"name":38,"class":6},1]