Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).
NCT ID: NCT06799351
Last Updated: 2025-02-12
Study Results
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Basic Information
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RECRUITING
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2025-02-07
2030-03-31
Brief Summary
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Unfortunately, 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.
This 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.
Primary Objectives:
To evaluate if gut microbiome profiles differ between patients:
1. with and without symptomatic improvement of CIPN.
2. receiving rectal ozone therapy and those receiving placebo.
Secondary Objectives:
To evaluate the relationship between gut microbiome composition and:
1. Health-related quality of life,
2. Anxiety and depression,
3. Biochemical markers of oxidative stress and inflammation.
Main Trial Endpoints.
Changes from baseline at the end of ozone therapy (week 16) in:
* Gut microbiome profile
* Patient-reported numbness and tingling
* Neuropathy severity (QLQ-CIPN20 scale)
* Paresthesia toxicity grade (CTCAE v.5.0)
Secondary Trial Endpoints.
Changes from baseline at the end of ozone therapy (week 16) in:
* Patient-reported quality of life (EQ-5D-5L questionnaire)
* Quality of life (QLQ-C30 questionnaire)
* Anxiety and depression levels (HADS questionnaire)
* Biochemical markers of oxidative stress
* Biochemical markers of inflammation
Trial Design:
This observational study will analyze data from patients enrolled in the randomized, triple-blind, placebo-controlled OzoParQT clinical trial (NCT06706544).
Trial Population in the OzoParQT trial (NCT06706544):
Adults (≥18 years) with any tumor type, experiencing CIPN-related paresthesias (numbness and/or tingling), with a toxicity grade ≥ 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0) for ≥ 3 months.
Intervention in the OzoParQT trial (NCT06706544).
All patients will receive standard care for their CIPN symptoms plus 40 sessions of rectal insufflation of an O3/O2 gas mixture over 16 weeks:
* Ozone group: O3/O2 concentration increasing from 10 to 30 µg/mL
* Control-placebo group: O2 only (0 µg/mL O3)
Study Duration:
Each patient will participate in this study (OzoParQTmicrob) for 16 weeks, concurrent with the ozone therapy intervention. The total planned project duration is 60 months.
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Detailed Description
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Unfortunately, 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.
This 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.
Primary Objectives:
To evaluate if gut microbiome profiles differ between patients:
1. with and without symptomatic improvement of CIPN.
2. receiving rectal ozone therapy and those receiving placebo.
Secondary Objectives:
To evaluate the relationship between gut microbiome composition and:
1. Health-related quality of life,
2. Anxiety and depression,
3. Biochemical markers of oxidative stress and inflammation.
Main Trial Endpoints.
Changes from baseline at the end of ozone therapy (week 16) in:
* Gut microbiome profile
* Patient-reported numbness and tingling
* Neuropathy severity (QLQ-CIPN20 scale)
* Paresthesia toxicity grade (CTCAE v.5.0)
Secondary Trial Endpoints.
Changes from baseline at the end of ozone therapy (week 16) in:
* Patient-reported quality of life (EQ-5D-5L questionnaire)
* Quality of life (QLQ-C30 questionnaire)
* Anxiety and depression levels (HADS questionnaire)
* Biochemical markers of oxidative stress
* Biochemical markers of inflammation
Trial Design:
This observational study will analyze data from patients enrolled in the randomized, triple-blind, placebo-controlled OzoParQT clinical trial (NCT06706544).
Trial Population in the OzoParQT trial (NCT06706544):
Adults (≥18 years) with any tumor type, experiencing CIPN-related paresthesias (numbness and/or tingling), with a toxicity grade ≥ 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0) for ≥ 3 months.
Intervention in the OzoParQT trial (NCT06706544).
All patients will receive standard care for their CIPN symptoms plus 40 sessions of rectal insufflation of an O3/O2 gas mixture over 16 weeks:
* Ozone group: O3/O2 concentration increasing from 10 to 30 µg/mL
* Control-placebo group: O2 only (0 µg/mL O3)
Study Duration:
Each patient will participate in this study (OzoParQTmicrob) for 16 weeks, concurrent with the ozone therapy intervention. The total planned project duration is 60 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
QUADRUPLE
* researchers who carry out biochemical determinations or functional tests,
* researchers who carry out the gut microbiome analysis,
* statisticians
Study Groups
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Ozone Group
Drug: Ozone (O3/O2). Treatment: Usual treatment + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Ozone therapy
Usual treatment (by their oncologist or hematologist) + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Oxygen Group (Placebo)
Drug: Oxygen (O2). Treatment: Usual treatment + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Oxygen (placebo)
Usual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Interventions
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Ozone therapy
Usual treatment (by their oncologist or hematologist) + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Oxygen (placebo)
Usual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 1\. Adults \> = 18 years old.
* 2\. Previous treatment with any chemotherapy because of any tumor.
* 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.
* 4\. Without neurotoxic chemotherapy \> = 3 months.
* 5\. Cancer disease is stable or in remission.
* 6\. Life expectancy \> = 6 months.
* 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.
* 8\. To sign and date the specific informed consent of both studies (OzoParQT and OzoParQTmicrob)
Exclusion Criteria
* 2\. A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods.
* 3\. Suspected symptoms are due to diabetic or compressive neuropathy.
* 4\. Severe psychiatric disorders.
* 5\. Inability to complete the quality of life questionnaires.
* 6\. Elevation above 5 times the maximum limit of normal creatinine.
* 7\. Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures.
* 8\. Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy.
* 9\. Life expectancy (for any reason) \< 6 months.
* 10\. Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.
* 11\. Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.
18 Years
ALL
No
Sponsors
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Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Council of Gran Canaria
OTHER
CIBER (Infectious diseases)
UNKNOWN
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna
UNKNOWN
Bernardino Clavo, MD, PhD
OTHER
Responsible Party
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Bernardino Clavo, MD, PhD
Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital
Principal Investigators
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Bernardino Clavo, MD, PhD
Role: STUDY_CHAIR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Francisco Rodríguez-Esparragón, BSc, PhD
Role: STUDY_DIRECTOR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Jacob Lorenzo-Morales, Prof
Role: PRINCIPAL_INVESTIGATOR
Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias - Universidad de La Laguna (IUETSPC-ULL)
Francisco Rodríguez-Esparragón, BSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Bernardino Clavo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
Locations
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Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas, Las Palmas, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Ramakrishna C, Corleto J, Ruegger PM, Logan GD, Peacock BB, Mendonca S, Yamaki S, Adamson T, Ermel R, McKemy D, Borneman J, Cantin EM. Dominant Role of the Gut Microbiota in Chemotherapy Induced Neuropathic Pain. Sci Rep. 2019 Dec 30;9(1):20324. doi: 10.1038/s41598-019-56832-x.
Lin B, Wang Y, Zhang P, Yuan Y, Zhang Y, Chen G. Gut microbiota regulates neuropathic pain: potential mechanisms and therapeutic strategy. J Headache Pain. 2020 Aug 17;21(1):103. doi: 10.1186/s10194-020-01170-x.
Clavo B, Rodriguez-Abreu D, Galvan-Ruiz S, Federico M, Canovas-Molina A, Ramallo-Farina Y, Antonilli C, Benitez G, Fabelo H, Garcia-Lourve C, Gonzalez-Beltran D, Jorge IJ, Rodriguez-Esparragon F, Callico GM. Long-Term Effects of Ozone Treatment in Patients with Persistent Numbness and Tingling Secondary to Chemotherapy-Induced Peripheral Neuropathy. A Retrospective Study. Integr Cancer Ther. 2025 Jan-Dec;24:15347354241307038. doi: 10.1177/15347354241307038.
Bocci V, Borrelli E, Travagli V, Zanardi I. The ozone paradox: ozone is a strong oxidant as well as a medical drug. Med Res Rev. 2009 Jul;29(4):646-82. doi: 10.1002/med.20150.
Bocci V, Valacchi G. Nrf2 activation as target to implement therapeutic treatments. Front Chem. 2015 Feb 2;3:4. doi: 10.3389/fchem.2015.00004. eCollection 2015.
Bocci VA, Zanardi I, Travagli V. Ozone acting on human blood yields a hormetic dose-response relationship. J Transl Med. 2011 May 17;9:66. doi: 10.1186/1479-5876-9-66.
Clavo B, Canovas-Molina A, Diaz-Garrido JA, Canas S, Ramallo-Farina Y, Laffite H, Federico M, Rodriguez-Abreu D, Galvan S, Garcia-Lourve C, Gonzalez-Beltran D, Carames MA, Hernandez-Fleta JL, Serrano-Aguilar P, Rodriguez-Esparragon F. Effects of ozone therapy on anxiety and depression in patients with refractory symptoms of severe diseases: a pilot study. Front Psychol. 2023 Aug 4;14:1176204. doi: 10.3389/fpsyg.2023.1176204. eCollection 2023.
Clavo B, Canovas-Molina A, Ramallo-Farina Y, Federico M, Rodriguez-Abreu D, Galvan S, Ribeiro I, Marques da Silva SC, Navarro M, Gonzalez-Beltran D, Diaz-Garrido JA, Cazorla-Rivero S, Rodriguez-Esparragon F, Serrano-Aguilar P. Effects of Ozone Treatment on Health-Related Quality of Life and Toxicity Induced by Radiotherapy and Chemotherapy in Symptomatic Cancer Survivors. Int J Environ Res Public Health. 2023 Jan 13;20(2):1479. doi: 10.3390/ijerph20021479.
Clavo B, Martinez-Sanchez G, Rodriguez-Esparragon F, Rodriguez-Abreu D, Galvan S, Aguiar-Bujanda D, Diaz-Garrido JA, Canas S, Torres-Mata LB, Fabelo H, Tellez T, Santana-Rodriguez N, Fernandez-Perez L, Marrero-Callico G. Modulation by Ozone Therapy of Oxidative Stress in Chemotherapy-Induced Peripheral Neuropathy: The Background for a Randomized Clinical Trial. Int J Mol Sci. 2021 Mar 10;22(6):2802. doi: 10.3390/ijms22062802.
Clavo B, Rodriguez-Abreu D, Galvan S, Federico M, Martinez-Sanchez G, Ramallo-Farina Y, Antonelli C, Benitez G, Rey-Baltar D, Jorge IJ, Rodriguez-Esparragon F, Serrano-Aguilar P. Long-term improvement by ozone treatment in chronic pain secondary to chemotherapy-induced peripheral neuropathy: A preliminary report. Front Physiol. 2022 Aug 30;13:935269. doi: 10.3389/fphys.2022.935269. eCollection 2022.
Clavo B, Navarro M, Federico M, Borrelli E, Jorge IJ, Ribeiro I, Rodriguez-Melcon JI, Carames MA, Santana-Rodriguez N, Rodriguez-Esparragon F. Ozone Therapy in Refractory Pelvic Pain Syndromes Secondary to Cancer Treatment: A New Approach Warranting Exploration. J Palliat Med. 2021 Jan;24(1):97-102. doi: 10.1089/jpm.2019.0597. Epub 2020 May 5.
Clavo B, Navarro M, Federico M, Borrelli E, Jorge IJ, Ribeiro I, Rodriguez-Melcon JI, Carames MA, Santana-Rodriguez N, Rodriguez-Esparragon F. Long-Term Results with Adjuvant Ozone Therapy in the Management of Chronic Pelvic Pain Secondary to Cancer Treatment. Pain Med. 2021 Sep 8;22(9):2138-2141. doi: 10.1093/pm/pnaa459. No abstract available.
Clavo B, Rodriguez-Esparragon F, Rodriguez-Abreu D, Martinez-Sanchez G, Llontop P, Aguiar-Bujanda D, Fernandez-Perez L, Santana-Rodriguez N. Modulation of Oxidative Stress by Ozone Therapy in the Prevention and Treatment of Chemotherapy-Induced Toxicity: Review and Prospects. Antioxidants (Basel). 2019 Nov 26;8(12):588. doi: 10.3390/antiox8120588.
Galie M, Covi V, Tabaracci G, Malatesta M. The Role of Nrf2 in the Antioxidant Cellular Response to Medical Ozone Exposure. Int J Mol Sci. 2019 Aug 17;20(16):4009. doi: 10.3390/ijms20164009.
Hidalgo-Tallon J, Menendez-Cepero S, Vilchez JS, Rodriguez-Lopez CM, Calandre EP. Ozone therapy as add-on treatment in fibromyalgia management by rectal insufflation: an open-label pilot study. J Altern Complement Med. 2013 Mar;19(3):238-42. doi: 10.1089/acm.2011.0739. Epub 2012 Oct 9.
Szklener K, Rudzinska A, Juchaniuk P, Kabala Z, Mandziuk S. Ozone in Chemotherapy-Induced Peripheral Neuropathy-Current State of Art, Possibilities, and Perspectives. Int J Mol Sci. 2023 Mar 9;24(6):5279. doi: 10.3390/ijms24065279.
Tricarico G, Travagli V. The Relationship between Ozone and Human Blood in the Course of a Well-Controlled, Mild, and Transitory Oxidative Eustress. Antioxidants (Basel). 2021 Dec 4;10(12):1946. doi: 10.3390/antiox10121946.
Viebahn-Haensler R, Leon Fernandez OS. Ozone in Medicine. The Low-Dose Ozone Concept and Its Basic Biochemical Mechanisms of Action in Chronic Inflammatory Diseases. Int J Mol Sci. 2021 Jul 23;22(15):7890. doi: 10.3390/ijms22157890.
Other Identifiers
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PIFIISC24/37
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PI23/01324
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIGC'23/24
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-385-1
Identifier Type: -
Identifier Source: org_study_id
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