NCT06706544: OzoParQT

Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy

Recruiting now Phase 2, PHASE3 Last updated 11 February 2025

What this trial tests

Phase 2, PHASE3 trial testing Ozone therapy in Chemotherapy Induced Peripheral Neuropathy (CIPN) in 42 participants. Currently enrolling.

Timeline

7 February 2025

Primary endpoint
31 December 2029

31 March 2030

Quick facts

Lead sponsor	Bernardino Clavo, MD, PhD
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	42
Start date	7 February 2025
Primary completion	31 December 2029
Estimated completion	31 March 2030
Sites	1 location across Spain

Drugs / interventions tested

• Ozone therapy — full drug profile →
• Oxygen (placebo) — full drug profile →

Conditions studied

• Chemotherapy Induced Peripheral Neuropathy (CIPN) — all drugs for Chemotherapy Induced Peripheral Neuropathy (CIPN) →
• Paresthesia — all drugs for Paresthesia →
• Numbness — all drugs for Numbness →
• Tingling — all drugs for Tingling →

Sponsor

Bernardino Clavo, MD, PhD — full company profile →

Who can join

18 and older, any sex, with Chemotherapy Induced Peripheral Neuropathy (CIPN) or Paresthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. Long-Term Effects of Ozone Treatment in Patients with Persistent Numbness and Tingling Secondary to Chemotherapy-Induced Peripheral Neuropathy. A Retrospective Study.
   Clavo B, Rodríguez-Abreu D, Galván-Ruiz S, Federico M, et al · · 2025 · cited 5× · PMID 39797612 · DOI 10.1177/15347354241307038
2. Ozone Treatment in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Review of Rationale and Research Directions.
   Clavo B, Cánovas-Molina A, Federico M, Martínez-Sánchez G, et al · · 2025 · cited 2× · PMID 40723162 · DOI 10.3390/cancers17142278
3. Effectiveness and cost-effectiveness of ozone treatment in patients with paraesthesia (numbness, tingling) secondary to chemotherapy-induced peripheral neuropathy: randomized, triple-blind clinical trial (OzoParQT).
   Clavo B, Cánovas-Molina A, Cazorla-Rivero S, Martínez-Sánchez G, et al · · 2026 · PMID 41572235 · DOI 10.1186/s12885-025-15399-9
4. Effects of ozone treatment on chemotherapy-induced peripheral neuropathy: a promising research area.
   Clavo B, Cánovas-Molina A, García-Lourve C, Cazorla-Rivero S, et al · · 2025 · PMID 40070187 · DOI 10.4103/mgr.medgasres-d-24-00074