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New treatment option for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Official title Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).
ClinicalTrials.gov ID: NCT06799351
What this study is testing
What is Ozone therapy?
Ozone therapy is an investigational medicine, being studied as a potential treatment for chemotherapy induced peripheral neuropathy (cipn).
Also referred to as Ozone treatment, O3/O2 gas mixture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy (CT), often requiring dose reductions or treatment interruptions, which can compromise efficacy of the planned CT (limiting its efficacy). Additionally, CIPN usually decreases patients' quality of life.
- Phase 3: a large, late-stage study
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 0\. Patients who agree to participate in the assigned by chance clinical trial OzoParQT, and who also agree to participate in this study of gut...
- 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...
- 4\. Without neurotoxic chemotherapy \> = 3 months.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 0\. Patients who agree to participate in the assigned by chance 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...
- 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...
- 8\. To sign and date the specific informed consent of both studies (OzoParQT and OzoParQTmicrob)
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Las Palmas, Las Palmas, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Palmas, Las Palmas, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.