Using ozone therapy to treat pain from chemotherapy-induced nerve damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and cost-effectiveness of ozone therapy as an additional treatment for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN). It is a randomized controlled trial involving 42 patients with cancer who have experienced persistent pain due to CIPN for at least three months. Participants will receive either ozone therapy or a placebo in conjunction with their usual treatment, and various health-related quality of life metrics will be assessed. The study also aims to explore the impact of ozone therapy on oxidative stress, chronic inflammation, and patient anxiety and depression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Adults \> = 18 years old.
* 2\. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy \> = 6 months.
* 3\. Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy, toxicity Grade 2 or higher according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0, for \> = 3 months and without the inclusion of new treatments for pain and/or neuropathy for \> = 1 month.
* 4\. "Average pain" \> = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) \> = 3 months beyond chemotherapy completion.
* 5\. Pregnant women cannot participate in the clinical trial.
* 6\. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit and accept the use of appropriate contraceptive methods at least from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
* 7\. Patients who have signed and dated the study 's specific informed consent

Exclusion Criteria:

* 1\. Age \< 18 years old.
* 2\. Pregnancy at the time of enrollment.
* 3\. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
* 4\. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.
* 5\. Psychiatric illness or social situations that would limit compliance with study requirements.
* 6\. Those who are unable to fill in the scales used to measure quality of life variables
* 7\. Specific liver enzymes \[Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \> 5 times the upper limit of normal
* 8\. Increased creatinine \> 3 times the upper limit of normal.
* 9\. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
* 10\. Uncontrolled cancer disease.
* 11\. Leptomeningeal carcinomatosis.
* 12\. Life expectancy \< 6 months
* 13\. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
* 14\. Known allergy to ozone.
* 15.Patients who do not meet all the inclusion criteria.

Where it's running

• Complejo Hospitalario Materno Insular
  Las Palmas de Gran Canaria, Las Palmas, Spain Recruiting
• Hospital Universitario de Gran Canaria Dr. Negrín
  Las Palmas de Gran Canaria, Las Palmas, Spain Recruiting

Study contacts

• Principal investigator: Delvys Rodríguez-Abreu, MD — Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, Spain
• Study coordinator: Bernardino Clavo, MD, PhD
• Email: bernardinoclavo@gmail.com
• Phone: (34)928449278

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VMD-3866 topical gel for chemotherapy-induced nerve pain

  This trial will test whether a non-opioid topical gel called VMD-3866 can reduce pain in adults with chemotherapy-induced peripheral neuropathy.

  Recruiting Phase 2 VM Therapeutics LLC · London, UK · NCT07072468

• Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling

  This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.

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• SIR2501 plus Paclitaxel for solid tumors

  This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.

  Recruiting at 3 sites Phase 2 Sironax USA, Inc. · Hollywood, Florida and 4 other locations · NCT07765446

• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

  This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.

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• Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy

  Researchers are testing a small, at-home device that you wear on the ear to see if it eases nerve pain from chemotherapy.

  Recruiting University of Miami · Coral Gables, Florida · NCT07596030

• Blood extracellular vesicles to detect chemotherapy-related nerve damage.

  We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07558447

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.