Ozone therapy for numbness and tingling from chemotherapy

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 of rectal ozone therapy in improving symptoms of numbness and tingling caused by chemotherapy-induced peripheral neuropathy (CIPN). It involves a randomized comparison between ozone and placebo (oxygen) treatments over 16 weeks, with a focus on patients' self-perceived levels of paresthesia and health-related quality of life. The study aims to provide insights into the potential benefits of ozone therapy as an adjunct treatment for CIPN, which currently has limited therapeutic options.

Why it matters

Who can join: the full rules

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) from the National Cancer Institute of EEUU, v.5.0) for \> = 3 months.
* 4\. Without neurotoxic chemotherapy \> = 3 months.
* 5\. Cancer disease is stable or in remission.
* 6\. Life expectancy \> = 6 months.
* 7\. 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 14 days before the first ozone therapy session up to 14 days after the last one.
* 8\. To sign and date the study-specific informed consent

Exclusion Criteria:

* 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.
* 5\. Inability to complete the quality of life questionnaires.
* 6\. Elevation above 5 times the maximum limit of normal creatinine.
* 7\. Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures.
* 8\. Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy.
* 9\. Life expectancy (for any reason) \< 6 months.
* 10\. Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.
* 11\. Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.
* 12\. Not meeting each and every one of the inclusion criteria

Where it's running

• Dr. Negrín University Hospital
  Las Palmas, Las Palmas, Spain Recruiting

Study contacts

• Principal investigator: Himar Fabelo, BSc, PhD — Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain
• Study coordinator: Bernardino Clavo, MD, PhD
• Email: bernardinoclavo@gmail.com
• Phone: 34928449278

Similar studies

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

• Examining gut microbiome profiles in patients with chemotherapy-induced neuropathy

  This study is trying to see if the gut bacteria of patients getting ozone therapy for chemotherapy-related nerve pain can help explain why some feel better while others don’t.

  Recruiting Phase 2/3 Hospital Universitario de Gran Canaria Doctor Negrín · Las Palmas, Las Palmas · NCT06799351

• 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.

  Recruiting at 3 sites Azienda Sanitaria dell'Alto Adige · Bolzano, Bolzano and 3 other locations · NCT07780955

• Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy

  This study tests whether adding a structured exercise program to electroacupuncture helps cancer survivors with CIPN more than electroacupuncture alone.

  Recruiting at 2 sites Show Chwan Memorial Hospital · Changhua, Changhua and 1 other locations · NCT07700901

• Virtual exercise program to help with chemotherapy-induced nerve symptoms

  This trial tests whether a remote, personalized exercise program (EX-CIPN) can reduce CIPN symptoms and related disability in cancer survivors who have persistent neuropathy after chemotherapy, compared with usual care.

  Recruiting Phase 3 University Health Network, Toronto · Toronto, Ontario · NCT07481149

• Acupuncture and compression to prevent chemotherapy-induced nerve damage in breast cancer

  This trial will test whether wearing compression garments and/or receiving acupuncture during taxane chemotherapy can prevent chemotherapy-induced peripheral neuropathy in adults with early-stage breast cancer.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07377279

• PEA and Scutellaria combined with exercise for chemotherapy-related nerve pain

  This trial will see if taking PEA and Scutellaria together with therapeutic exercise helps adults who have nerve pain after chemotherapy.

  Recruiting University of Palermo · Palermo, Italia · NCT07352514

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.