In short
There is currently 1 ongoing clinical trial investigating treatments for paraesthesia, a condition characterized by numbness and tingling sensations. This trial focuses specifically on paraesthesia caused by chemotherapy and is being conducted in Spain. The study is exploring ozone therapy as a potential treatment option to help reduce symptoms and improve quality of life for patients experiencing chemotherapy-induced peripheral neuropathy.
Clinical trial locations
Ozone Treatment for Numbness and Tingling from Chemotherapy in Patients with Peripheral Neuropathy: A Clinical Trial
This clinical trial is investigating whether ozone therapy can help patients who experience numbness and tingling as a side effect of chemotherapy. The condition, known as chemotherapy-induced peripheral neuropathy, affects many cancer patients and can significantly impact their daily lives and overall comfort.
Main inclusion criteria:
- Adults aged 18 years or older
- Previous chemotherapy treatment for any type of tumor
- Clinical diagnosis of moderate or severe paraesthesia caused by chemotherapy-induced peripheral neuropathy, lasting at least 3 months
- No neurotoxic chemotherapy received for at least 3 months before joining the study
- Stable cancer or cancer in remission (not currently growing or spreading)
- Life expectancy of at least 6 months
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study period
- Willingness to sign informed consent
Main exclusion criteria:
- Paraesthesia not caused by chemotherapy-induced neuropathy
- Mild symptoms (less than Grade 2 severity)
- Patients outside the specified age range
Focus and goal of the trial:
The study aims to determine whether ozone therapy can reduce symptoms of numbness and tingling in patients who developed these sensations after chemotherapy treatment. The treatment involves administering a mixture of ozone and oxygen through rectal insufflation, meaning the gas mixture is introduced into the body through the rectum. Participants will receive the treatment over 16 weeks, with follow-up assessments continuing for up to 28 weeks total. The researchers will measure changes in the level of numbness and tingling patients experience, as well as their overall quality of life. The study also looks at whether patients experience improvements in anxiety and depression levels.
Throughout the trial, participants will go through several stages: an initial assessment to establish baseline conditions, the 16-week treatment period with ozone therapy, a mid-treatment evaluation, a 12-week follow-up period after treatment ends, and a final comprehensive assessment. This structured approach allows researchers to carefully track how the treatment affects symptoms over time and whether any benefits persist after treatment stops.
Investigational drug:
The trial is testing ozone therapy, which involves the administration of ozone (a form of oxygen) to see if it can improve patients' symptoms and enhance their overall quality of life. Ozone therapy is believed to enhance oxygen delivery to tissues and may help modulate the immune response, though researchers are still working to fully understand how it works at the molecular level. This therapy is classified under alternative and complementary medicine, and this trial represents ongoing research to better understand its effectiveness and safety for treating chemotherapy-related nerve damage.
Summary
Currently, there is one active clinical trial for paraesthesia, specifically focused on cases caused by chemotherapy treatment. This trial is being conducted in Spain and represents an exploratory approach to managing chemotherapy-induced peripheral neuropathy using ozone therapy. The study reflects growing interest in alternative and complementary treatments for nerve damage caused by cancer treatments, as many patients continue to experience these uncomfortable symptoms long after their chemotherapy has ended. The trial's comprehensive approach, with 16 weeks of treatment and 12 weeks of follow-up, will help researchers understand both the immediate and lasting effects of this therapeutic approach.
