[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bernardino Clavo, MD, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":245},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,57,100,129,163,194,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100617994","patients-referred-to-the-chronic-pain-unit-for-palliative-treatment-with-ozone-therapy-between-2026-and-2029-100617994",false,"NCT07325851","Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029.","Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029. Prospective Study EPOOzo-2.","EPOOzo-2","Inclusion Criteria:\n\n* 1\\. Adults ≥ 18 years old.\n* 2\\. Patients referred to the Chronic Pain Unit of the Dr. Negrín University Hospital for symptomatic\u002Fpalliative treatment with ozone therapy because conventional treatment does not exist, has failed, has offered insufficient results, or is associated with high risk\u002Fmorbidity.\n* 3\\. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.\n* 4\\. Patients have no contraindications for ozone treatment.\n* 5\\. Patients must sign the specific Informed Consent for this study and for the ozone treatment.\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years old.\n* 2\\. Psychiatric illness or social situations that would limit compliance with study requirements.\n\nContraindication or disability to attend scheduled treatments.\n\n* 3\\. Contraindication or disability to attend scheduled treatments.\n* 4\\. Uncontrolled clinical conditions (e.g., severe heart failure, massive hemorrhage, status epilepticus).\n* 5\\. Life expectancy \\\u003C 6 months.\n* 6\\. Known allergy to ozone.\n* 7\\. Hemochromatosis (for systemic ozone treatment).\n* 8\\. Pregnancy (for systemic ozone treatment).\n* 9\\. Significant Glucose-6-Phosphate Dehydrogenase deficiency (Favism) (for systemic ozone treatment).\n* 10\\. Patients who do not meet the inclusion criteria.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","40 Weeks","OBSERVATIONAL","The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms who have been referred to the Dr. Negrín University Hospital Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between January 2026 and December 2029. Additionally, the study aims to evaluate several specific symptoms, hyperspectral and thermal images, non-invasive clinical parameters related to the Autonomic Nervous System (such as heart rate variability, electrochemical skin conductance, and vibration perception thresholds), oxidative stress and inflammatory parameters, and gut microbiota composition.",[26,27,28,29,30],"Chemotherapy-Induced Peripheral Neuropathy","Radiation Toxicity","Chronic Pain","Delayed Wound Healing","Refractory Symptoms",[32,33,34,35,36,37,38,39,40,41,42,43],"Ozone Therapy","Health-related quality of life","Chemotherapy-induced Peripheral Neuropathy","Radiation-induced toxicity","Hyperspectral imaging","Infrared imaging","Heart Rate Variability","Sudoscan","Vibrometry","Oxidative stress","Gut Microbiota","Anxiety and Depression","NOT_YET_RECRUITING","2025-12-23",{"date":47,"type":48},"2026-01-08","ACTUAL",{"date":50,"type":21},"2026-01-14",{"date":52,"type":21},"2030-06-30",{"name":54,"class":55},"Bernardino Clavo, MD, PhD","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":68,"studyType":23,"phases":4,"briefSummary":69,"conditions":70,"keywords":80,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.","FEMALE",{"count":67,"type":21},38,"4 Months","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[71,27,72,73,74,75,76,77,78,79],"Pelvic Toxicity","Chemotherapy Toxicity","Gynecological Tumors","Radiation Proctitis","Radiation Cystitis","Vaginal Mucositis","Vulvar Mucositis","Quality of Life","Dysbiosis",[81,82,83,84,85,86,87,88,89,90,79],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Radiotherapy","Chemotherapy","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","2025-12-16",{"date":93,"type":48},"2025-12-22",{"date":95,"type":21},"2026-01-15",{"date":97,"type":21},"2028-03-31",{"name":54,"class":55},2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":23,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":56},"100471350","patients-referred-to-the-chronic-pain-unit-for-palliative-treatment-with-ozone-therapy-between-2022-and-2025-100471350","NCT05417737","Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025","Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025. (EPOOzo)","EPOOzo","Inclusion Criteria:\n\n1. Adults \\> = 18 years old.\n2. Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic\u002Fpalliative treatment with ozone therapy because conventional treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.\n3. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.\n4. Patients have no contraindications for ozone treatment.\n5. Patients have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years old.\n2. Psychiatric illness or social situations that would limit compliance with study requirements.\n3. Those who are incapable to fill in the scales used to measure variables.\n4. Hemodynamically or clinically unstable patients or uncontrolled severe illness.\n5. Uncontrolled cancer disease requiring chemotherapy treatment.\n6. Life expectancy \\\u003C 6 months\n7. Contraindication or disability or to attend scheduled treatments.\n8. Known allergy to ozone.\n9. Pregnancy at the time of enrollment (for systemic ozone therapy). 10 Hemochromatosis (for systemic ozone therapy).\n\n11\\. Known significant glucose-6-phosphate dehydrogenase deficiency (favism, acute hemolytic anemia) (for systemic ozone therapy).\n\n12\\. Patients who do not meet all the inclusion criteria",{"count":109,"type":21},105,"28 Weeks","The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms, who have been referred to the HUGCDN Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between June-2022 and December-2025",[27,113,34,29,28,114],"Chemotherapeutic Toxicity","Refractory Pain",[34,35,116,117,118,33,43,83,119],"Cancer-treatment side effects","Delayed wound healing","Chronic pain","Refractory pain","RECRUITING","2025-08-25",{"date":123,"type":48},"2025-09-02",{"date":125,"type":48},"2022-06-15",{"date":127,"type":21},"2026-06-30",{"name":54,"class":55},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":141,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":99},"100385529","phase-2-ozone-therapy-in-chemotherapy-induced-peripheral-neuropathy-rct-o3npiq-100385529","NCT04299893","Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)","Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)","O3NPIQ","Inclusion Criteria:\n\n* 1\\. Adults \\> = 18 years old.\n* 2\\. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy \\> = 6 months.\n* 3\\. Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy, toxicity Grade 2 or higher according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0, for \\> = 3 months and without the inclusion of new treatments for pain and\u002For neuropathy for \\> = 1 month.\n* 4\\. \"Average pain\" \\> = 3\u002F10 according to the Brief Pain Inventory-Short Form (BPI-SF) \\> = 3 months beyond chemotherapy completion.\n* 5\\. Pregnant women cannot participate in the clinical trial.\n* 6\\. 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 the 14 days prior to the first ozone therapy session up to 14 days after the last one.\n* 7\\. Patients who have signed and dated the study 's specific informed consent\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years old.\n* 2\\. Pregnancy at the time of enrollment.\n* 3\\. Women with childbearing potential who are unwilling to perform a pregnancy test and\u002For employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one.\n* 4\\. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.\n* 5\\. Psychiatric illness or social situations that would limit compliance with study requirements.\n* 6\\. Those who are unable to fill in the scales used to measure quality of life variables\n* 7\\. Specific liver enzymes \\[Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \\> 5 times the upper limit of normal\n* 8\\. Increased creatinine \\> 3 times the upper limit of normal.\n* 9\\. Hemodynamically or clinically unstable patients or uncontrolled severe illness.\n* 10\\. Uncontrolled cancer disease.\n* 11\\. Leptomeningeal carcinomatosis.\n* 12\\. Life expectancy \\\u003C 6 months\n* 13\\. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.\n* 14\\. Known allergy to ozone.\n* 15.Patients who do not meet all the inclusion criteria.","100 Years",{"count":139,"type":21},42,"INTERVENTIONAL",[142,143],"PHASE2","PHASE3","The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy",[34,146,147],"Pain, Neuropathic","Pain Syndrome",[149,150,151,152,153,154,155,156],"complementary and integrative medicine","cost-effectiveness ratio","chemotherapy-induced peripheral neuropathy","pain","ozone therapy","quality of life related to health","shared decision-making tool","randomized controlled trial",{"date":123,"type":48},{"date":159,"type":48},"2020-11-30",{"date":161,"type":21},"2027-12-31",{"name":54,"class":55},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":65,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":173,"conditions":174,"keywords":180,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":193,"locationsCount":56},"100578807","gene-and-molecular-pathways-of-ozone-treatment-response-in-gynecological-tumor-patients-with-chronic-pelvic-pain-secondary-to-cancer-treatment-100578807","NCT06816095","Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment","Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy","OzoGynEpigen","Inclusion Criteria:\n\n* Adult women (\\>=18 years old) with gynecological tumors treated with radiotherapy-chemotherapy.\n* Cancer disease is stable or in remission.\n* Life expectancy \\> = 6 months.\n* Patients included in the group of patients with pelvic pain must have a clinical, radiological, endoscopic, or histopathological diagnosis that their pain is not secondary to the oncological process.\n* Patients included in the group of patients with pelvic pain must have pain for \\>= 3 months duration, with an intensity \\>= 3 on the Visual Analog Scale (VAS), or classified as toxicity \\>= Grade-2 of the CTCAE v.5.0 of the National Cancer Institute of the USA.\n* Signed and dated informed consent specific to this study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Severe psychiatric disorders.\n* Inability to complete the quality of life questionnaires.\n* Active neoplasia requiring recent initiation (\\\u003C 3 months) of systemic or local treatment.\n* Life expectancy (for any reason) \\\u003C 6 months.\n* Failure to meet all inclusion criteria",{"count":172,"type":21},40,"Gynecological cancers, including those affecting the ovaries, uterus, and cervix, represent a significant health burden for women. While survival rates have improved, many women experience chronic pelvic pain secondary to cancer treatment, especially radiotherapy and chemotherapy. This treatment-induced pelvic pain can be of difficult management and significantly affects patients' quality of life.\n\nIn our experience, ozone therapy has emerged as a promising complementary treatment for pain relief in patients with chronic diseases, including side effects of cancer treatment. However, the genetic and epigenetic mechanisms influencing its effectiveness have not yet been thoroughly studied.\n\nThe aim of this prospective study is to analyze how ozone therapy modulates the expression of certain genes and its impact on epigenetic clocks, which could help predict pain response.",[175,176,177,178,179],"Chronic Pelvic Pain Syndrome (CPPS)","Radiation-Induced Disorder","Radiotherapy Side Effects","Side Effect of Chemotherapy","Gynecological Cancers",[176,177,181,175,179,182,183,184,185,83,78,186],"Cancer survivors","gene expression","epigenetic clocks","side effects of cancer treatment","Toxicity of chemotherapy","oxidative stress","2025-02-10",{"date":189,"type":48},"2025-02-12",{"date":187,"type":48},{"date":192,"type":21},"2027-08-14",{"name":54,"class":55},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":140,"phases":203,"briefSummary":204,"conditions":205,"keywords":210,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":56},"100577519","phase-2-gut-microbiome-profiles-in-patients-with-chemotherapy-induced-neuropathy-in-the-rct-ozoparqt-nct06706544-100577519","NCT06799351","Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).","Evaluation of the Gut Microbiome Profiles in Patients with Chemotherapy-induced Peripheral Neuropathy Treated in the Randomized Clinical Trial with Ozone OzoParQT (NCT06706544).","OzoParQTmicrob","Inclusion Criteria:\n\n* 0\\. Patients who agree to participate in the randomized clinical trial OzoParQT, and who also agree to participate in this study of gut microbiota by providing stool samples.\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 specific informed consent of both studies (OzoParQT and OzoParQTmicrob)\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",{"count":139,"type":21},[142,143],"Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy (CT), often requiring dose reductions or treatment interruptions, which can compromise efficacy of the planned CT (limiting its efficacy). Additionally, CIPN usually decreases patients' quality of life.\n\nUnfortunately, effective treatments for CIPN are limited. Emerging evidence suggests potential benefits of rectal ozone therapy and points to a possible role of the gut microbiome in CIPN development and treatment response.\n\nThis observational study, ancillary to the randomized clinical trial (RCT) OzoParQT (NCT06706544), investigates the relationship between gut microbiome composition and CIPN severity in patients receiving rectal ozone therapy.\n\nPrimary Objectives:\n\nTo evaluate if gut microbiome profiles differ between patients:\n\n1. with and without symptomatic improvement of CIPN.\n2. receiving rectal ozone therapy and those receiving placebo.\n\nSecondary Objectives:\n\nTo evaluate the relationship between gut microbiome composition and:\n\n1. Health-related quality of life,\n2. Anxiety and depression,\n3. Biochemical markers of oxidative stress and inflammation.\n\nMain Trial Endpoints.\n\nChanges from baseline at the end of ozone therapy (week 16) in:\n\n* Gut microbiome profile\n* Patient-reported numbness and tingling\n* Neuropathy severity (QLQ-CIPN20 scale)\n* Paresthesia toxicity grade (CTCAE v.5.0)\n\nSecondary Trial Endpoints.\n\nChanges from baseline at the end of ozone therapy (week 16) in:\n\n* Patient-reported quality of life (EQ-5D-5L questionnaire)\n* Quality of life (QLQ-C30 questionnaire)\n* Anxiety and depression levels (HADS questionnaire)\n* Biochemical markers of oxidative stress\n* Biochemical markers of inflammation\n\nTrial Design:\n\nThis observational study will analyze data from patients enrolled in the randomized, triple-blind, placebo-controlled OzoParQT clinical trial (NCT06706544).\n\nTrial Population in the OzoParQT trial (NCT06706544):\n\nAdults (≥18 years) with any tumor type, experiencing CIPN-related paresthesias (numbness and\u002For tingling), with a toxicity grade ≥ 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0) for ≥ 3 months.\n\nIntervention in the OzoParQT trial (NCT06706544).\n\nAll patients will receive standard care for their CIPN symptoms plus 40 sessions of rectal insufflation of an O3\u002FO2 gas mixture over 16 weeks:\n\n* Ozone group: O3\u002FO2 concentration increasing from 10 to 30 µg\u002FmL\n* Control-placebo group: O2 only (0 µg\u002FmL O3)\n\nStudy Duration:\n\nEach patient will participate in this study (OzoParQTmicrob) for 16 weeks, concurrent with the ozone therapy intervention. The total planned project duration is 60 months.",[206,207,208,209],"Chemotherapy Induced Peripheral Neuropathy (CIPN)","Paresthesia","Numbness","Tingling",[211,212,213,214,215,153,216,217,218,186,219],"Chemotherapy induced peripheral neuropathy","paresthesia","numbness and tingling","side effect of cancer treatment","toxicity of chemotherapy","quality of life","anxiety","depression","gut microbiota",{"date":189,"type":48},{"date":222,"type":48},"2025-02-07",{"date":224,"type":21},"2030-03-31",{"name":54,"class":55},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":140,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":244,"locationsCount":56},"100570384","phase-2-ozone-treatment-in-paresthesia-numbness-tingling-secondary-to-chemotherapy-induced-peripheral-neuropathy-100570384","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",{"count":139,"type":21},[142,143],"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.",[206,207,208,209],[211,212,213,214,215,153,216,217,218,239,186],"hyperspectral imaging",{"date":241,"type":48},"2025-02-11",{"date":222,"type":48},{"date":224,"type":21},{"name":54,"class":55},""]