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RECRUITINGINTERVENTIONAL

Prevention of CIPN Using Compressive Therapy

Prevention of Chemotherapy-induced Polyneuropathy (CIPN) Using Compressive Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of treatment with taxanes and platinum-based drugs, significantly impacting the quality of life of oncology patients. Symptoms such as reduced sensitivity and pain may persist even after treatment ends. Research has shown that compression therapy using gloves and stockings effectively reduces the incidence of CIPN, improves patient adherence to treatment, and has no severe side effects. A study at the Chemotherapy Unit of the Comprehensive Oncology Care Clinic, Masaryk Memorial Cancer Institute, will investigate the efficacy of this therapy. Tight-fitting gloves and compression stockings will be used to limit the flow of cytotoxic agents to peripheral areas. Effectiveness will be assessed through quality-of-life questionnaires, hand strength and coordination tests, and laboratory analyses to identify predictive markers of neuropathy. The study aims to enhance CIPN prevention and integrate this method into clinical practice.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18-70 years at the time of signing the willing to sign a consent form (IC). - Signed willing to sign a consent form. - Breast cancer stages I-III - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2. - (Neo)adjuvant treatment with paclitaxel weekly. Who Should NOT Join This Trial: - Metastatic disease. - History of neuropathy/vasculopathy and its pharmacological treatment. - Type I or II diabetes. - Stroke within the last 6 months. - Prior treatment with taxanes and/or cisplatin derivatives. - Peripheral arterial ischemia. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age 18-70 years at the time of signing the informed consent (IC). * Signed informed consent. * Breast cancer stages I-III * ECOG performance status 0-2. * (Neo)adjuvant treatment with paclitaxel weekly. Exclusion Criteria: * Metastatic disease. * History of neuropathy/vasculopathy and its pharmacological treatment. * Type I or II diabetes. * Stroke within the last 6 months. * Prior treatment with taxanes and/or cisplatin derivatives. * Peripheral arterial ischemia.

Treatments Being Tested

DEVICE

Compression using surgical gloves and compression knee socks

Compression therapy will be applied using surgical gloves and compression knee socks. The compression itself will take place on the principle of compressing the limbs, which will narrow the blood vessels and thereby limit the flow of cytostatics to the peripheral parts of the body. This is believed to reduce damage to nerve fibers. Special knee socks with compression of 20-30 mm Hg and latex/nitrile surgical gloves will be used for pressure therapy. The size of the compression aids will be determined by the nursing staff (gloves will be a tight-fitting size; they will not cause discomfort). The patients will wear the compression aids for a specific amount of time before administering paclitaxel, throughout paclitaxel infusion, and after the infusion.

Locations (1)

Masaryk Memorial Cancer Institute
Brno, Czechia