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Recruiting Not applicable NCT06823440

Prevention of CIPN Using Compressive Therapy

No applicable phase (e.g. observational)
Conditions: CIPN in Adjuvant Breast Cancer Patients

Sponsor: Martina Lojova

trial.available_in: БГ
Overview
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 can participate
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.
Interventions
Compression using surgical gloves and compression knee socks
DEVICE
Locations 1
Czech Republic (1)
Masaryk Memorial Cancer Institute
Brno
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.02.2025
Completion date
31.12.2028
Registry ID
NCT06823440
Source
clinicaltrials.gov
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