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. 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.
Eligibility criteria
Qualifiers
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) from the National Cancer Institute of EEUU, v.5.0) for > = 3 months.
4. Without neurotoxic chemotherapy > = 3 months.
Disqualifiers
1. Age < 18 years.
2. A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods.
3. Suspected symptoms are due to diabetic or compressive neuropathy.
4. Severe psychiatric disorders.
Trial design
Treatments tested in this trial
- Ozone therapy
- Oxygen (placebo)
Treatment groups
Sponsors and collaborators
Bernardino Clavo, MD, PhD
Lead sponsor
Dr. Negrin University Hospital
Sponsor institution
Council of Gran Canaria
Collaborator
Centers for International Business Education and Research
Collaborator
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)
Collaborator
Complejo Hospitalario Universitario Insular Materno Infantil
Collaborator
Servicio Canario de Salud
Collaborator
Institute for Applied Microelectronics, University of Las Palmas de Gran Canaria, Spain
Collaborator
Instituto de Salud Carlos III
Collaborator