Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBernardino Clavo, MD, PhD
About this trial
The goal of this phase II/III randomized clinical trial is to evaluate the effect of adding rectal ozone therapy to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN). Ozone treatment consists of the rectal insufflation of 180 - 300 milliliters of an ozone/oxygen gas mixture.
The main questions to answer are:
1. Can ozone therapy improve patients' self-perceived level of numbness and tingling? 2. Can ozone therapy improve patients' self-perceived health-related quality of life (HRQoL)?
In 42 patients with chronic numbness and tingling secondary to chemotherapy, the researchers will compare:
* the addition of rectal ozone insufflations * 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.
Before treatment, after treatment, and 12 weeks after treatment, they will be evaluated:
* Several questionnaires about neuropathy, quality of life, and anxiety and depression. * Biochemical parameters of oxidative stress and inflammation * Hyperspectral images of hands and feet * Toxicity of procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1. Age < 18 years.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ozone therapy
DrugUsual 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)
DrugUsual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Ozone GroupExperimental treatment 1 intervention
Group B: Oxygen Group (Placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in "numbness and tingling" self-perceived by patients at the end of follow-up (week 28 after the commencement of ozone treatment)
Self-reported evaluation of the percentage of "numbness and/or tingling" regarding the basal level. From 100% (basal level, 0% improvement) to 0% (no numbness and tingling, 100% improvement).
Time frame
28 weeks2
Change from Baseline in quality of life by the EQ-...
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 an extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analog scale (0 = worst health patient can imagine, 100 = best health patient can imagine).
Time frame
28 weeksSecondary outcomes
1
Direct hospital costs
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits…) during the 28 weeks for the study (in euros).
Time frame
28 weeks2
Change from baseline in "numbness and tingling" self-perceived by patients at the end of ozone treatment.
Self-reported evaluation of the percentage of "numbness and/or tingling" regarding the basal level. From 100% (basal level, 0% improvement) to 0% (no numbness and tingling, 100% improvement).
Time frame
163
Changes from baseline in the Grade of toxicity of parestesias (numbness, tingling) according to the CTCAE v.5.0. scale at the end of ozone treatment.
Changes from baseline in the Grade of toxicity of paresthesias (numbness, tingling) according to the CTCAE v.5.0. scale (from the National Cancer Institute of EEUU). Range from: Grade = (asymptomatic or mild symptoms) to Grade 3 (severe symptoms, limiting self-care activities in daily life).
Time frame
16 weeks4
Changes from baseline in the Grade of toxicity of sensory neuropathy according to the CTCAE v.5.0. scale at the end of ozone treatment.
Changes from baseline in the Grade of toxicity of paresthesias (numbness, tingling) according to the CTCAE v.5.0. scale (from the National Cancer Institute of EEUU). Range from: Grade = (asymptomatic or mild symptoms) to Grade 4 (life-threatening consequences, urgent intervention indicated).
Time frame
16 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bernardino Clavo, MD, PhD
Lead sponsor
Hospital Universitario de Gran Canaria Doctor Negrín
Sponsor institution
Council of Gran Canaria
Collaborator
Centers for International Business Education and Research
Collaborator
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborator
Complejo Hospitalario Universitario Insular Materno Infantil
Collaborator
Servicio Canario de Salud
Collaborator
University of Las Palmas de Gran Canaria
Collaborator
Instituto de Salud Carlos III
Collaborator
Source ClinicalTrials.gov