Examining gut microbiome profiles in patients with chemotherapy-induced neuropathy

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 study investigates the relationship between gut microbiome composition and the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing rectal ozone therapy. It aims to determine if gut microbiome profiles differ between patients who experience symptomatic improvement and those who do not, as well as between those receiving ozone therapy and a placebo. The study also evaluates the impact of gut microbiome on health-related quality of life, anxiety, depression, and biochemical markers of oxidative stress and inflammation. Participants will provide stool samples to analyze their microbiome profiles throughout the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 0\. Patients who agree to participate in the randomized clinical trial OzoParQT, and who also agree to participate in this study of gut microbiota by providing stool samples.
* 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 specific informed consent of both studies (OzoParQT and OzoParQTmicrob)

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

• Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
  Las Palmas, Las Palmas, Spain Recruiting

Study contacts

• Principal investigator: Jacob Lorenzo-Morales, Prof — Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias - Universidad de La Laguna (IUETSPC-ULL)
• 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.

• Ozone therapy for numbness and tingling from chemotherapy

  This study is testing if ozone therapy can help reduce numbness and tingling in cancer patients who have nerve damage from chemotherapy.

  Recruiting Phase 2/3 Hospital Universitario de Gran Canaria Doctor Negrín · Las Palmas, Las Palmas · NCT06706544

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

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

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

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

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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.