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Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)

ConditionsChemotherapy-induced Peripheral NeuropathyPain, NeuropathicPain Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBernardino Clavo, MD, PhD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ozone

    Drug

    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.

  • Oxygen

    Drug

    Control Group: Standard treatment + Oxygen (O2) 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 groups
Group A: Ozone GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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").

Time frame
16 weeks
2

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).

Time frame
16 weeks

Secondary outcomes

1

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)

Time frame
16 weeks
2

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)

Time frame
16 weeks
3

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

Time frame
16 weeks
4

Change from Baseline in Biochemical parameters of inflammation (at the end of ozone therapy)

Serum levels of pro-inflammatory interleukins and TNFalpha

Time frame
16 weeks

Other outcomes

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

Servicio Canario de Salud

Collaborator

Instituto de Salud Carlos III

Collaborator

Red de Investigación en Servicios de Salud en Enfermedades Crónicas

Collaborator

Fundación DISA, Spain

Collaborator

Fundación Española del Dolor (FED)

Collaborator

Council of Gran Canaria

Collaborator

Source ClinicalTrials.gov
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