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.
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
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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.
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1. C…
Trial Locations
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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