[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tingling\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tingling":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100577519","phase-2-gut-microbiome-profiles-in-patients-with-chemotherapy-induced-neuropathy-in-the-rct-ozoparqt-nct06706544-100577519",false,"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","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","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.",[28,29,30,31],"Chemotherapy Induced Peripheral Neuropathy (CIPN)","Paresthesia","Numbness","Tingling",[33,34,35,36,37,38,39,40,41,42,43],"Chemotherapy induced peripheral neuropathy","paresthesia","numbness and tingling","side effect of cancer treatment","toxicity of chemotherapy","ozone therapy","quality of life","anxiety","depression","oxidative stress","gut microbiota","RECRUITING","2025-02-10",{"date":47,"type":48},"2025-02-12","ACTUAL",{"date":50,"type":48},"2025-02-07",{"date":52,"type":21},"2030-03-31",{"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":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":75,"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":20,"type":21},[24,25],"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.",[28,29,30,31],[33,34,35,36,37,38,39,40,41,70,42],"hyperspectral imaging",{"date":72,"type":48},"2025-02-11",{"date":50,"type":48},{"date":52,"type":21},{"name":54,"class":55}]