Prevention of CIPN Using Compressive Therapy

NCT06823440 | Recruiting

• 1 other identifier: MOU-2024-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CIPN in Adjuvant Breast Cancer Patients

Keywords

CIPN; breast cancer; compressive therapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Changes in reported EORTC QLQ CIPN20 subscales

  The preventive effect of compression therapy will be evaluated based on changes reported in a survey, using self-reported neuropathy assessed with EORTC QLQ-CIPN 20, which contains 20 items divided into three subscales assessing sensory, motor, and autonomic symptoms. Each item is scored on a Likert scale ranging from 1 (not at all) to 4 (very much). Scores will be converted to a 0-100 scale, with higher scores representing more higher scores represent more symptoms/problems.

  Before paclitaxel course (baseline) and completion paclitaxel course (standardly 12 weeks)

Secondary Outcomes (2)

• Changes in reported EORTC QLQ-C30 subscales

  Before paclitaxel course (baseline), after the sixth cycle of paclitaxel (standardly 6 weeks), after completion paclitaxel course (standardly 12 weeks) and six months after completition paclitaxel course

• Changes in reported EORTC QLQ CIPN20 subscales

  Before paclitaxel course (baseline), after the sixth cycle of paclitaxel (standardly 6 weeks), after completion paclitaxel course (standardly 12 weeks) and six months after completition paclitaxel course

Other Outcomes (1)

• Changes in hand grip test a grip ability test

  Before paclitaxel course (baseline), after the sixth cycle of paclitaxel (standardly 6 weeks), after completion paclitaxel course (standardly 12 weeks) and six months after completition paclitaxel course

Study Arms (3)

A - compression short

EXPERIMENTAL

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.

Device: Compression using surgical gloves and compression knee socks

B - compression long

EXPERIMENTAL

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.

Device: Compression using surgical gloves and compression knee socks

C - no compression

NO INTERVENTION

Nonrandomized control group with no compression intervention.

Interventions

Compression using surgical gloves and compression knee socks DEVICE

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.

A - compression short; B - compression long

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Martina Lojova: lead

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, 60200, Czechia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tatiana Ciprova, MBA

  Masaryk Memorial Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Lojova, Ph.D.

CONTACT

+420543136232; martina.lojova@mou.cz

Iveta Selingerova, Ph.D.

CONTACT

+420543136720; iveta.selingerova@mou.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tatiana Ciprova, lead nurse, Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)