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

Recruiting Phase 2 Phase 3 Interventional Study
Chemotherapy Induced Peripheral Neuropathy (CIPN) Paresthesia Numbness Tingling
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Bernardino Clavo, MD, PhD · Other
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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. C…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * 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) f…
Contacts

Bernardino Clavo, MD, PhD

34928449278

bernardinoclavo@gmail.com

CONTACT

Francisco Rodríguez-Esparragón, BSc, PhD

34928449288

afrodesp@gmail.com

CONTACT