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

Status: Recruiting
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Contact Information
Primary
Martina Lojova, Ph.D.
martina.lojova@mou.cz
+420543136232
Backup
Iveta Selingerova, Ph.D.
iveta.selingerova@mou.cz
+420543136720
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Experimental: A - compression short
In Arm A, patients will wear compression gloves beginning 15 min before the start of paclitaxel infusion, during infusion, and for 30 min post-paclitaxel infusion. They will also wear the compression knee socks beginning 15 minutes before the start of paclitaxel infusion, during infusion, and for 90 minutes post-paclitaxel infusion.
Experimental: B - compression long
In Arm B, patients will wear compression gloves beginning 15 min before the start of paclitaxel infusion, during infusion, and for 90 minutes post-paclitaxel infusion. They will also wear the compression knee socks beginning 15 minutes before the start of paclitaxel infusion, during infusion, and for 24 hours post-paclitaxel infusion.
No_intervention: C - no compression
Nonrandomized control group with no compression intervention.
Related Therapeutic Areas
Sponsors
Leads: Martina Lojova

This content was sourced from clinicaltrials.gov