Back to resultsOzone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ) (O3NPIQ)
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy, Pain, Neuropathic, Pain Syndrome
Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ozone
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 1. Adults > = 18 years old.
- 2. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy > = 6 months.
- 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/or neuropathy for > = 1 month.
- 4. "Average pain" > = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) > = 3 months beyond chemotherapy completion.
- 5. Pregnant women cannot participate in the clinical trial.
- 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.
- 7. Patients who have signed and dated the study 's specific informed consent
Exclusion Criteria:
- 1. Age < 18 years old.
- 2. Pregnancy at the time of enrollment.
- 3. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
- 4. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.
- 5. Psychiatric illness or social situations that would limit compliance with study requirements.
- 6. Those who are unable to fill in the scales used to measure quality of life variables
- 7. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal
- 8. Increased creatinine > 3 times the upper limit of normal.
- 9. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
- 10. Uncontrolled cancer disease.
- 11. Leptomeningeal carcinomatosis.
- 12. Life expectancy < 6 months
- 13. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
- 14. Known allergy to ozone.
- 15.Patients who do not meet all the inclusion criteria.
Sites / Locations
- Complejo Hospitalario Materno InsularRecruiting
- Hospital Universitario de Gran Canaria Dr. NegrínRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ozone Group
Control Group
Arm Description
Drug: Ozone Ozone Group: Usual treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks. Other Names: O3
Drug: Oxygen Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks. Other Names: O2
Outcomes
Primary Outcome Measures
Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at the end of ozone therapy)
Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes").
Direct Hospital Cost (at the end of ozone therapy)
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros).
Secondary Outcome Measures
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36v2) questionnaire (at the end of ozone therapy)
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Change from Baseline in Biochemical parameters of oxidative stress (at the end of ozone therapy)
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Change from Baseline in Biochemical parameters of inflammation (at the end of ozone therapy)
Serum levels of pro-inflammatory interleukins and TNFalpha
Change from Baseline in Hyperspectral image of painful area (at the end of ozone therapy)
Assessment of the percentage of reflectance for each wavelength
Change from Baseline in Levels of anxiety and depression according to the Hamilton scale (at the end of ozone therapy)
Clinician-administered depression assessment scale with 17 items pertaining to symptoms of depression experienced over the past week. Each item is scored from 0 (better, no alteration) to 2 (worse level of alteration) for items with three options, or from or from 0 (better, no alteration) to 4 (worse level of alteration) for items with five options. Overall score is from 0 (better, no anxiety/depression) to 52 (worse, very severe anxiety/depression).
Change from Baseline in Nerve conduction studies in the painful area (at the end of ozone therapy)
Assessment of nerve conduction velocity (in m/s)
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at the end of ozone therapy)
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at 12 weeks after the end of ozone therapy)
Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes")
Direct Hospital Cost (at 12 weeks after the end of ozone therapy)
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros)
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at 12 weeks after the end of ozone therapy)
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36v2) questionnaire (at 12 weeks after the end of ozone therapy)
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Change from Baseline in Biochemical parameters of oxidative stress (at 12 weeks after the end of ozone therapy)
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Change from Baseline in Biochemical parameters of inflammation (at 12 weeks after the end of ozone therapy)
Serum levels of pro-inflammatory interleukins and TNFalpha
Change from Baseline in Hyperspectral image of painful area (at 12 weeks after the end of ozone therapy)
Assessment of the percentage of reflectance for each wavelength
Change from Baseline in Levels of anxiety and depression according to the Hamilton scale (at 12 weeks after the end of ozone therapy)
Clinician-administered depression assessment scale with 17 items pertaining to symptoms of depression experienced over the past week. Each item is scored from 0 (better, no alteration) to 2 (worse level of alteration) for items with three options, or from or from 0 (better, no alteration) to 4 (worse level of alteration) for items with five options. Overall score is from 0 (better, no anxiety/depression) to 52 (worse, very severe anxiety/depression)
Change from Baseline in Nerve conduction studies in the painful area (at 12 weeks after the end of ozone therapy)
Assessment of nerve conduction velocity (in m/s)
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at 12 weeks after the end of ozone therapy)
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Full Information
NCT ID
NCT04299893
First Posted
March 5, 2020
Last Updated
November 10, 2022
Sponsor
Bernardino Clavo, MD, PhD
Collaborators
Servicio Canario de Salud, Instituto de Salud Carlos III, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Fundación DISA, Spain, Fundación Española del Dolor (FED)
1. Study Identification
Unique Protocol Identification Number
NCT04299893
Brief Title
Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
Acronym
O3NPIQ
Official Title
Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bernardino Clavo, MD, PhD
Collaborators
Servicio Canario de Salud, Instituto de Salud Carlos III, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Fundación DISA, Spain, Fundación Española del Dolor (FED)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) decreases the quality of life of patients and can lead to a decrease and/or interruption of the chemotherapy treatment-limiting its effectiveness. The therapeutic measures for the CIPN are very limited in their number and efficacy.
Main Objectives: 1) To evaluate the clinical effect on the health-related quality of life (HRQOL) of adding ozone to the usual patient´s treatment with persistent pain because of CIPN. 2) Estimate the additional costs and evaluate the cost-effectiveness ratio.
Secondary Objectives: To evaluate the evolution of 3) oxidative stress and chronic inflammation through biochemical measurements; 4) anxiety and depression of patients; 5) the diagnostic and predictive value of hyperspectral imaging in the assessment of pain; 6) the acceptability of patients to a shared decision-making (SDM) tool.
METHODOLOGY: Randomized controlled trial (RCT) phase II-III, randomized, triple-blind; 42 patients with any kind of cancer treated with any kind of chemotherapy, with CIPN of grade > = 2 for > = 3 months.
TREATMENT: All patients will receive: usual treatment + 40 rectal insufflation sessions of O3/O2 in 16 weeks:
Ozone-Arm (n = 21): concentration of O3/O2 increasing from 10 to 30 μg/ml.
Control-placebo- Arm (n = 21): concentration of O3/O2 = 0 μg/ml.
Main Variables: At the end of treatment with O3/O2 the following variables will be analyzed: 1) "average pain" secondary to CIPN following the Brief Pain Inventory-Short Form (BPI-SF); 2) health-related quality of life (HRQOL) and utilities using EQ-5D-5L and SF-36 quality of life questionnaires; 3) Direct costs.
Secondary Variables: 3) biochemical parameters of oxidative stress and inflammation; 4) Hamilton scale for anxiety and depression; 5) hyperspectral images; 6) acceptability of patients to a shared decision-making (SDM) tool.
Assessments at weeks: 0 (baseline), 16 (end of O3/O2 insufflations, objective), and 28 (end of follow-up, control).
Length of treatment: 16 weeks.
Follow-up: 12 weeks after finishing O3/O2 insufflation.
Planned length of the clinical trial: 36 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Pain, Neuropathic, Pain Syndrome
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Standard treatment + ozone therapy (O3/O2) versus Standard treatment + oxygen (O2) as placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking of: patients, Medical Oncologists (clinical assessment), investigators obtaining other parameters (quality of life, biochemical and clinical parameters, hyperspectral images), investigators for statistical analysis
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ozone Group
Arm Type
Experimental
Arm Description
Drug: Ozone Ozone Group: Usual treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Other Names: O3
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Drug: Oxygen Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Other Names: O2
Intervention Type
Drug
Intervention Name(s)
Ozone
Other Intervention Name(s)
O3
Intervention Description
Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
O2
Intervention Description
Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at the end of ozone therapy)
Description
Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes").
Time Frame
16 weeks
Title
Direct Hospital Cost (at the end of ozone therapy)
Description
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
Description
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Time Frame
16 weeks
Title
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36v2) questionnaire (at the end of ozone therapy)
Description
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Time Frame
16 weeks
Title
Change from Baseline in Biochemical parameters of oxidative stress (at the end of ozone therapy)
Description
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Time Frame
16 weeks
Title
Change from Baseline in Biochemical parameters of inflammation (at the end of ozone therapy)
Description
Serum levels of pro-inflammatory interleukins and TNFalpha
Time Frame
16 weeks
Title
Change from Baseline in Hyperspectral image of painful area (at the end of ozone therapy)
Description
Assessment of the percentage of reflectance for each wavelength
Time Frame
16 weeks
Title
Change from Baseline in Levels of anxiety and depression according to the Hamilton scale (at the end of ozone therapy)
Description
Clinician-administered depression assessment scale with 17 items pertaining to symptoms of depression experienced over the past week. Each item is scored from 0 (better, no alteration) to 2 (worse level of alteration) for items with three options, or from or from 0 (better, no alteration) to 4 (worse level of alteration) for items with five options. Overall score is from 0 (better, no anxiety/depression) to 52 (worse, very severe anxiety/depression).
Time Frame
16 weeks
Title
Change from Baseline in Nerve conduction studies in the painful area (at the end of ozone therapy)
Description
Assessment of nerve conduction velocity (in m/s)
Time Frame
16 weeks
Title
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at the end of ozone therapy)
Description
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Time Frame
16 weeks
Title
Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at 12 weeks after the end of ozone therapy)
Description
Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes")
Time Frame
28 weeks
Title
Direct Hospital Cost (at 12 weeks after the end of ozone therapy)
Description
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros)
Time Frame
28 weeks
Title
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at 12 weeks after the end of ozone therapy)
Description
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Time Frame
28 weeks
Title
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36v2) questionnaire (at 12 weeks after the end of ozone therapy)
Description
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Time Frame
28 weeks
Title
Change from Baseline in Biochemical parameters of oxidative stress (at 12 weeks after the end of ozone therapy)
Description
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Time Frame
28 weeks
Title
Change from Baseline in Biochemical parameters of inflammation (at 12 weeks after the end of ozone therapy)
Description
Serum levels of pro-inflammatory interleukins and TNFalpha
Time Frame
28 weeks
Title
Change from Baseline in Hyperspectral image of painful area (at 12 weeks after the end of ozone therapy)
Description
Assessment of the percentage of reflectance for each wavelength
Time Frame
28 weeks
Title
Change from Baseline in Levels of anxiety and depression according to the Hamilton scale (at 12 weeks after the end of ozone therapy)
Description
Clinician-administered depression assessment scale with 17 items pertaining to symptoms of depression experienced over the past week. Each item is scored from 0 (better, no alteration) to 2 (worse level of alteration) for items with three options, or from or from 0 (better, no alteration) to 4 (worse level of alteration) for items with five options. Overall score is from 0 (better, no anxiety/depression) to 52 (worse, very severe anxiety/depression)
Time Frame
28 weeks
Title
Change from Baseline in Nerve conduction studies in the painful area (at 12 weeks after the end of ozone therapy)
Description
Assessment of nerve conduction velocity (in m/s)
Time Frame
28 weeks
Title
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at 12 weeks after the end of ozone therapy)
Description
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Adults > = 18 years old.
2. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy > = 6 months.
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/or neuropathy for > = 1 month.
4. "Average pain" > = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) > = 3 months beyond chemotherapy completion.
5. Pregnant women cannot participate in the clinical trial.
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.
7. Patients who have signed and dated the study 's specific informed consent
Exclusion Criteria:
1. Age < 18 years old.
2. Pregnancy at the time of enrollment.
3. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
4. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.
5. Psychiatric illness or social situations that would limit compliance with study requirements.
6. Those who are unable to fill in the scales used to measure quality of life variables
7. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal
8. Increased creatinine > 3 times the upper limit of normal.
9. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
10. Uncontrolled cancer disease.
11. Leptomeningeal carcinomatosis.
12. Life expectancy < 6 months
13. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
14. Known allergy to ozone.
15.Patients who do not meet all the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernardino Clavo, MD, PhD
Phone
(34)928449278
Email
bernardinoclavo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Delvys Rodríguez-Abreu, MD
Phone
(34)928441779
Email
drodabr@gobiernodecanarias.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardino Clavo, MD, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedro G Serrano-Aguilar, MD, PhD
Organizational Affiliation
Servicio de Evaluación. Servicio Canario de Salud. Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Delvys Rodríguez-Abreu, MD
Organizational Affiliation
Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo M Callico, Prof, PhD
Organizational Affiliation
Institute for Applied Microelectronics, University of Las Palmas de G. C., Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Rodríguez-Esparragón, BSc, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernardino Clavo, MD, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Materno Insular
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delvys Rodríguez-Abreu, MD
Email
delvysra@yahoo.com
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrín
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardino Clavo, MD, PhD
Email
bernardinoclavo@gmail.com
First Name & Middle Initial & Last Name & Degree
Saray Galván, MD
First Name & Middle Initial & Last Name & Degree
Francisco Rodríguez-Esparragón, BSc, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33802143
Citation
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.
Results Reference
background
PubMed Identifier
36111149
Citation
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.
Results Reference
background
PubMed Identifier
23549581
Citation
Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.
Results Reference
result
PubMed Identifier
21427067
Citation
Durand JP, Deplanque G, Montheil V, Gornet JM, Scotte F, Mir O, Cessot A, Coriat R, Raymond E, Mitry E, Herait P, Yataghene Y, Goldwasser F. Efficacy of venlafaxine for the prevention and relief of oxaliplatin-induced acute neurotoxicity: results of EFFOX, a randomized, double-blind, placebo-controlled phase III trial. Ann Oncol. 2012 Jan;23(1):200-205. doi: 10.1093/annonc/mdr045. Epub 2011 Mar 22.
Results Reference
result
PubMed Identifier
24687190
Citation
Albers JW, Chaudhry V, Cavaletti G, Donehower RC. Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database Syst Rev. 2014 Mar 31;(3):CD005228. doi: 10.1002/14651858.CD005228.pub4.
Results Reference
result
PubMed Identifier
24733808
Citation
Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.
Results Reference
result
PubMed Identifier
19260079
Citation
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.
Results Reference
result
PubMed Identifier
21575276
Citation
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.
Results Reference
result
PubMed Identifier
25699252
Citation
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.
Results Reference
result
PubMed Identifier
23102757
Citation
Clavo B, Ceballos D, Gutierrez D, Rovira G, Suarez G, Lopez L, Pinar B, Cabezon A, Morales V, Oliva E, Fiuza D, Santana-Rodriguez N. Long-term control of refractory hemorrhagic radiation proctitis with ozone therapy. J Pain Symptom Manage. 2013 Jul;46(1):106-12. doi: 10.1016/j.jpainsymman.2012.06.017. Epub 2012 Oct 26.
Results Reference
result
PubMed Identifier
31779159
Citation
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.
Results Reference
result
PubMed Identifier
32379556
Citation
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.
Results Reference
result
PubMed Identifier
33738491
Citation
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.
Results Reference
result
Learn more about this trial
Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
We'll reach out to this number within 24 hrs