In short
There is currently 1 ongoing clinical trial investigating treatments for hypoaesthesia, a condition characterized by reduced sensation or numbness. This trial is exploring ozone therapy as a potential treatment for numbness and tingling caused by chemotherapy, specifically in patients with chemotherapy-induced peripheral neuropathy. The trial is being conducted in Spain.
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 reduce numbness and tingling in patients who developed these symptoms as a side effect of chemotherapy treatment. The condition being studied is called chemotherapy-induced peripheral neuropathy, which occurs when certain chemotherapy drugs damage the nerves in the body, particularly in the hands and feet.
Main inclusion criteria:
- Participants must be at least 18 years old
- Must have previously received chemotherapy for any type of cancer
- Must have moderate or severe numbness and tingling (paresthesia) lasting at least 3 months, caused by chemotherapy
- Must not have received nerve-damaging chemotherapy for at least 3 months
- Cancer must be stable or in remission
- Life expectancy of at least 6 months
- Women of childbearing age must have a negative pregnancy test and use effective birth control during the study period
Main exclusion criteria:
- Patients whose numbness and tingling is not caused by chemotherapy
- Patients with mild symptoms (less than Grade 2)
- Patients outside the specified age range
Trial focus and approach:
The study will investigate whether adding ozone therapy to standard care can help improve symptoms and quality of life for patients. The treatment involves administering a mixture of ozone and oxygen through rectal insufflation, which means the gas mixture is introduced into the body through the rectum. The trial will run for 28 weeks in total, with the treatment phase lasting 16 weeks followed by a 12-week follow-up period. Throughout the study, researchers will measure changes in the severity of numbness and tingling, as well as overall quality of life and psychological well-being.
Investigational treatment:
The trial is testing ozone therapy, which uses ozone (a form of oxygen) to potentially improve oxygen delivery to damaged tissues and help regulate the body's immune response. Researchers believe this may help reduce the uncomfortable sensations of numbness and tingling experienced by patients with chemotherapy-induced nerve damage.
Summary
Currently, there is one active clinical trial addressing hypoaesthesia related to chemotherapy side effects. This trial is taking place in Spain and focuses specifically on patients who have completed cancer treatment but continue to experience moderate to severe numbness and tingling as a lasting effect of their chemotherapy. The study is exploring ozone therapy as a potential complementary treatment approach, with the goal of improving symptom management and quality of life for affected patients. The research represents an investigation into alternative therapeutic options for a condition that can significantly impact daily activities and overall well-being.
