Dominant Role of the Gut Microbiota in Chemotherapy Induced Neuropathic Pain.
Chandran Ramakrishna, Jose Corleto, Paul M Ruegger...
https://pubmed.ncbi.nlm.nih.gov/31889131Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
ID06799351
Evaluation of Gut Microbiome Profiles in Patients with Chemotherapy-induced Peripheral Neuropathy in the Randomized Clinical Trial OzoParQT (NCT06706544)
Led by Bernardino Clavo, MD, PhD · Updated on 2025-02-12
42
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
B
Bernardino Clavo, MD, PhD
Lead Sponsor
F
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and distressing side effect of chemotherapy that often leads to dose reductions or interruptions, which can lessen treatment effectiveness and lower quality of life. This research is an observational study linked to a randomized clinical trial (OzoParQT) that explores how the gut microbiome relates to CIPN severity and response to rectal ozone therapy in adults with various tumors experiencing CIPN symptoms for at least three months. Participants receive standard care plus 40 sessions of rectal insufflation with either an O3/O2 gas mixture (ozone therapy) gradually increasing in concentration or oxygen alone as a placebo, over a period of 16 weeks. The study compares gut microbiome profiles and symptom changes between those who experience improvement and those who do not, as well as between the ozone and placebo groups. During the 16 weeks, participants will provide stool samples and complete questionnaires assessing neuropathy severity, quality of life, anxiety, and depression. Researchers will also measure biochemical markers of oxidative stress and inflammation. The main outcomes focus on changes in gut microbiome and neuropathy symptoms, while secondary measures include quality of life and mental health assessments. The total project is planned to last 60 months.
CONDITIONS
Brief Title
Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Previous treatment with any chemotherapy for any tumor
- Clinical diagnosis of numbness or tingling (paresthesia) due to CIPN with toxicity grade 2 or higher for at least 3 months
- No neurotoxic chemotherapy received within the last 3 months
- Cancer is stable or in remission
- Life expectancy of at least 6 months
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use contraception from 14 days before first ozone therapy to 14 days after the last session
- Signed informed consent for both the main trial and this gut microbiome study
You will not qualify if you...
- Age under 18 years
- Pregnant or breastfeeding women, or women of childbearing potential not using adequate contraception
- Symptoms suspected to be caused by diabetic or compressive neuropathy
- Severe psychiatric disorders
- Inability to complete quality of life questionnaires
- Creatinine levels more than 5 times above normal
- Hemodynamically or clinically unstable patients requiring urgent intervention
- Active cancer progressing with recent systemic treatment or neurotoxic chemotherapy
- Life expectancy less than 6 months
- Known allergy to ozone, glucose 6 phosphate dehydrogenase deficiency, or hemochromatosis
- Contraindications to rectal ozone treatment or inability to attend regular treatments
- Failure to meet all inclusion criteria
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - 16 weeks
Participants receive usual care for chemotherapy-induced peripheral neuropathy along with either rectal ozone therapy or a placebo (oxygen) through rectal insufflation over 16 weeks.
40 treatment sessions over 16 weeks
Trial Site Locations
Total: 1 location
1
Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)
Las Palmas, Las Palmas, Spain, 35019
Actively Recruiting
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Research Team
B
Bernardino Clavo, MD, PhD
F
Francisco Rodríguez-Esparragón, BSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Published Research Related To This Trial
Gut microbiota regulates neuropathic pain: potential mechanisms and therapeutic strategy.
Binbin Lin, Yuting Wang, Piao Zhang...
https://pubmed.ncbi.nlm.nih.gov/32807072Long-Term Effects of Ozone Treatment in Patients with Persistent Numbness and Tingling Secondary to Chemotherapy-Induced Peripheral Neuropathy. A Retrospective Study.
Bernardino Clavo, Delvys Rodríguez-Abreu, Saray Galván-Ruiz...
https://pubmed.ncbi.nlm.nih.gov/39797612The ozone paradox: ozone is a strong oxidant as well as a medical drug.
Velio Bocci, Emma Borrelli, Valter Travagli...
https://pubmed.ncbi.nlm.nih.gov/19260079Nrf2 activation as target to implement therapeutic treatments.
Velio Bocci, Giuseppe Valacchi
https://pubmed.ncbi.nlm.nih.gov/25699252Ozone acting on human blood yields a hormetic dose-response relationship.
Velio A Bocci, Iacopo Zanardi, Valter Travagli
https://pubmed.ncbi.nlm.nih.gov/21575276Effects of ozone therapy on anxiety and depression in patients with refractory symptoms of severe diseases: a pilot study.
Bernardino Clavo, Angeles Cánovas-Molina, Juan A Díaz-Garrido...
https://pubmed.ncbi.nlm.nih.gov/37599784Effects of Ozone Treatment on Health-Related Quality of Life and Toxicity Induced by Radiotherapy and Chemotherapy in Symptomatic Cancer Survivors.
Bernardino Clavo, Angeles Cánovas-Molina, Yolanda Ramallo-Fariña...
https://pubmed.ncbi.nlm.nih.gov/36674232Modulation by Ozone Therapy of Oxidative Stress in Chemotherapy-Induced Peripheral Neuropathy: The Background for a Randomized Clinical Trial.
Bernardino Clavo, Gregorio Martínez-Sánchez, Francisco Rodríguez-Esparragón...
https://pubmed.ncbi.nlm.nih.gov/33802143Long-term improvement by ozone treatment in chronic pain secondary to chemotherapy-induced peripheral neuropathy: A preliminary report.
Bernardino Clavo, Delvys Rodríguez-Abreu, Saray Galván...
https://pubmed.ncbi.nlm.nih.gov/36111149