Authorised Phase II and Phase III (Integrated) Pain secondary to chemotherapy-induced peripheral neuropathy

Effectiveness and cost-effectiveness of Ozone therapy in patients with pain secondary to peripheral neuropathy induced by chemotherapy. Randomized, placebo-controlled, clinical trial

EU CTIS ID: 2024-518021-16-00

What this study is testing

To assess the clinical effect and impact on self-perceived health related quality of life (HRQOL) by addition of Ozone therapy to the standard management of patients with cancer and suffering painful chemotherapy-induced peripheral neuropathy Grade > = 2 for > 3 months. To estimate the additional cost and the ratio of cost-effectiveness of adding Ozone therapy to the regular treatment.

Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Adults > = 18 years old.
2. Cancer in any stage, treated with chemotherapy, and life expectancy > 6 months.
3. Clinical diagnosis painful chemotherapy-induced peripheral neuropathy, toxicity Grade > 2 according to the Common Toxicity Criteria for Adverse Events (CTCAE) del National Cancer Institute de 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) for > 3 months.
5. Pregnant women can not 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.

You likely can't join if

1. Age < 18 years old.
10. Neoplasia in progression
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.

See the full eligibility criteria

Who can join

1. Adults > = 18 years old.
2. Cancer in any stage, treated with chemotherapy, and life expectancy > 6 months.
3. Clinical diagnosis painful chemotherapy-induced peripheral neuropathy, toxicity Grade > 2 according to the Common Toxicity Criteria for Adverse Events (CTCAE) del National Cancer Institute de 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) for > 3 months.
5. Pregnant women can not 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 ʼs specific informed consent.

What rules you out

1. Age < 18 years old.
10. Neoplasia in progression
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.
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 is due to 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 uncapable 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.

The study team makes the final eligibility decision.

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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.