Prevention of CIPN Using Compressive Therapy

Martina Lojova

Status: Enrolling

Conditions: CIPN in Adjuvant Breast Cancer Patients

Treatments: Device: Compression using surgical gloves and compression knee socks

Study type: Interventional

Funder types: Other

Identifiers

NCT06823440

MOU-2024-03

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

A - compression short

Experimental group

Description:

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.

Treatment:

Device: Compression using surgical gloves and compression knee socks

B - compression long

Experimental group

Description:

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.

Treatment:

Device: Compression using surgical gloves and compression knee socks

C - no compression

No Intervention group

Description:

Nonrandomized control group with no compression intervention.