NCT04299893 (O3NPIQ) is a Phase 2, PHASE3 clinical trial of Ozone in Chemotherapy-induced Peripheral Neuropathy, sponsored by Bernardino Clavo, MD, PhD.

Who is sponsoring NCT04299893?

NCT04299893 is sponsored by Bernardino Clavo, MD, PhD.

What drugs are being tested in NCT04299893?

Interventions in NCT04299893: Ozone, Oxygen.

What condition does NCT04299893 study?

NCT04299893 studies Chemotherapy-induced Peripheral Neuropathy, Pain, Neuropathic, Pain Syndrome.

Is NCT04299893 still recruiting?

NCT04299893 is currently recruiting now. Last updated 2 September 2025.

Last reviewed 2025-09-02 · How we verify

NCT04299893: O3NPIQ

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2, PHASE3 Last updated 2 September 2025

What this trial tests

Phase 2, PHASE3 trial testing Ozone in Chemotherapy-induced Peripheral Neuropathy in 42 participants. Currently enrolling.

Timeline

30 November 2020

Primary endpoint
30 September 2027

31 December 2027

Quick facts

Lead sponsor	Bernardino Clavo, MD, PhD
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	30 November 2020
Primary completion	30 September 2027
Estimated completion	31 December 2027
Sites	2 locations across Spain

Drugs / interventions tested

Ozone (OZONE) — full drug profile →
Oxygen — full drug profile →

Conditions studied

Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →
Pain, Neuropathic — all drugs for Pain, Neuropathic →
Pain Syndrome — all drugs for Pain Syndrome →

Sponsor

Bernardino Clavo, MD, PhD — full company profile →

Who can join

Adults 18 to 100, any sex, with Chemotherapy-induced Peripheral Neuropathy or Pain, Neuropathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Pharmacological and Non-Pharmacological Therapeutics for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy.
Li Y, Lustberg MB, Hu S. · · 2021 · cited 36× · PMID 33673136 · DOI 10.3390/cancers13040766
Modulation by Ozone Therapy of Oxidative Stress in Chemotherapy-Induced Peripheral Neuropathy: The Background for a Randomized Clinical Trial.
Clavo B, Martínez-Sánchez G, Rodríguez-Esparragón F, Rodríguez-Abreu D, et al · · 2021 · cited 25× · PMID 33802143 · DOI 10.3390/ijms22062802
Integrated Medicine for Chemotherapy-Induced Peripheral Neuropathy.
Tsai CH, Lin YH, Li YS, Ho TL, et al · · 2021 · cited 12× · PMID 34502166 · DOI 10.3390/ijms22179257
Long-term improvement by ozone treatment in chronic pain secondary to chemotherapy-induced peripheral neuropathy: A preliminary report.
Clavo B, Rodríguez-Abreu D, Galván S, Federico M, et al · · 2022 · cited 11× · PMID 36111149 · DOI 10.3389/fphys.2022.935269
Long-Term Results with Adjuvant Ozone Therapy in the Management of Chronic Pelvic Pain Secondary to Cancer Treatment.
Clavo B, Navarro M, Federico M, Borrelli E, et al · · 2021 · cited 11× · PMID 33738491 · DOI 10.1093/pm/pnaa459
Effects of Ozone Treatment on Health-Related Quality of Life and Toxicity Induced by Radiotherapy and Chemotherapy in Symptomatic Cancer Survivors.
Clavo B, Cánovas-Molina A, Ramallo-Fariña Y, Federico M, et al · · 2023 · cited 10× · PMID 36674232 · DOI 10.3390/ijerph20021479
Ozone in Chemotherapy-Induced Peripheral Neuropathy-Current State of Art, Possibilities, and Perspectives.
Szklener K, Rudzińska A, Juchaniuk P, Kabała Z, et al · · 2023 · cited 8× · PMID 36982352 · DOI 10.3390/ijms24065279
Various gases for the treatment of neuropathic pain: mechanisms, current status, and future perspectives.
Liu Y, Shen T, Li Q, Yu X, et al · · 2025 · cited 6× · PMID 40300884 · DOI 10.4103/mgr.medgasres-d-24-00161

Verify or expand the search:

Other trials of Ozone

Trials testing the same drug.

NCT06133712 — Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief · NA · recruiting
NCT06130618 — The Effects of Ultrasound Guided Ozone and Lidocaine Injections in Piriformis Syndrome · NA · unknown
NCT05794087 — The Role of Macrophage Activation in Lung Injury Following Ozone Exposure · NA · recruiting
NCT06909305 — Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis · NA · completed
NCT05473000 — Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise · NA · completed

Other recruiting trials for Chemotherapy-induced Peripheral Neuropathy

Currently open trials in the same condition.

NCT07177820 — VGAIT for Chemotherapy-induced Peripheral Neuropathy · NA · recruiting
NCT07072468 — Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN) · Phase 2 · recruiting
NCT06389721 — Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy · recruiting
NCT06405542 — Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN) · Phase 1 · active not recruiting
NCT06162403 — Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longi · NA · recruiting

Other Bernardino Clavo, MD, PhD trials

Trials by the same sponsor.

NCT07259681 — Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox) · not yet recruiting
NCT07325851 — Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029. · not yet recruiting
NCT06816095 — Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Seconda · recruiting
NCT06799351 — Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544). · Phase 2, PHASE3 · recruiting
NCT06706544 — Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy · Phase 2, PHASE3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04299893 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bernardino Clavo, MD, PhD
Last refreshed: 2 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04299893.

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