Ozone Treatment for Numbness and Tingling from Chemotherapy in Patients with Peripheral Neuropathy: A Clinical Trial

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for paresthesia, which is a condition characterized by numbness and tingling. This condition can occur as a side effect of chemotherapy, known as chemotherapy-induced peripheral neuropathy. The trial will explore the use of a treatment involving ozone, a form of oxygen, to see if it can help reduce these symptoms and improve the quality of life for patients experiencing moderate to severe paresthesia.

The treatment involves using a mixture of ozone and oxygen, which is administered through a method called rectal insufflation. This means the gas mixture is introduced into the body through the rectum. The study aims to determine if adding ozone to the usual care for paresthesia can help patients feel better and improve their daily lives. The trial will also look at how this treatment affects patients’ overall health and well-being over a period of time.

Participants in the study will receive the treatment over a period of 16 weeks, with follow-up assessments continuing for up to 28 weeks. The study will measure changes in the level of numbness and tingling that patients feel, as well as their overall quality of life. The goal is to find out if this new approach can offer a beneficial addition to the current management of paresthesia caused by chemotherapy.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures.

The participant will be required to sign a consent form to confirm understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to evaluate the participant’s baseline condition.

This assessment will include a self-reported evaluation of paresthesia (numbness, tingling) and quality of life using specific questionnaires.

3 ozone treatment

The participant will receive ozone treatment administered rectally.

The treatment will be conducted over a period of 16 weeks, with sessions scheduled according to the study protocol.

4 mid-treatment evaluation

At the end of the ozone treatment period, a mid-treatment evaluation will be conducted.

This evaluation will assess changes in paresthesia and quality of life, as well as any changes in anxiety and depression levels.

5 follow-up period

Following the treatment phase, a follow-up period of 12 weeks will occur.

During this time, the participant’s condition will continue to be monitored, and additional assessments will be conducted.

6 final assessment

At the end of the follow-up period, a final assessment will be conducted.

This assessment will evaluate the overall changes in paresthesia, quality of life, and other health parameters from the baseline.

Who Can Join the Study?

Must be an adult, which means being 18 years old or older.
Must have received chemotherapy treatment for any type of tumor in the past.
Must have a clinical diagnosis of paresthesia, which is a feeling of numbness or tingling, caused by chemotherapy-induced peripheral neuropathy (CIPN). The symptoms should be moderate or more severe and have lasted for at least 3 months.
Must not have received any neurotoxic chemotherapy (chemotherapy that can harm the nerves) for at least 3 months.
The cancer must be stable or in remission, meaning it is not currently growing or spreading.
Must have a life expectancy of at least 6 months.
Women who can have children must have a negative pregnancy test before joining the study and agree to use effective birth control methods from 14 days before the first ozone therapy session until 14 days after the last session.
Must agree to participate by signing and dating the study’s specific informed consent form, which explains the details of the study.

Who Cannot Join the Study?

Patients who do not have paresthesia (numbness or tingling) caused by chemotherapy-induced neuropathy cannot participate.
Patients with paresthesia that is less than Grade 2 (mild symptoms) are not eligible.
Individuals who are not within the specified age range for the study cannot join.
Both male and female patients are eligible, so gender is not an exclusion factor.
Patients who are part of a vulnerable population are not excluded based on this criterion.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Oxygen

Ozone Therapy is being studied for its potential benefits in patients experiencing paresthesia, which includes symptoms like numbness and tingling, as a result of chemotherapy-induced peripheral neuropathy. This therapy involves the administration of ozone, a form of oxygen, to see if it can improve the patients’ perception of their symptoms and enhance their overall quality of life. The trial aims to determine if adding ozone therapy to the standard treatment can provide additional relief from these uncomfortable sensations.

Chemotherapy-Induced Peripheral Neuropathy – This condition occurs as a side effect of certain chemotherapy drugs, leading to damage in the peripheral nerves. It often manifests as paresthesia, which includes sensations of numbness and tingling, primarily in the hands and feet. The symptoms can range from mild discomfort to severe pain and may affect daily activities. Over time, the condition can progress, causing more persistent and widespread symptoms. The severity of the neuropathy can vary depending on the type and dose of chemotherapy received. It is a common issue for cancer patients undergoing treatment, impacting their quality of life.

Trial ID:

2024-517196-20-00

Protocol code:

OzoParQT

Trial Phase:

Therapeutic use (Phase IV)

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Ozone Treatment for Numbness and Tingling from Chemotherapy in Patients with Peripheral Neuropathy: A Clinical Trial

What is this study about?

Who Can Join the Study?

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