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NCT Number: NCT06823440

Prevention of CIPN Using Compressive Therapy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in reported EORTC QLQ CIPN20 subscales

    Time frame: Before paclitaxel course (baseline) and completion paclitaxel course (standardly 12 weeks)

    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.

Secondary outcomes

  1. Changes in reported EORTC QLQ-C30 subscales

    Time frame: 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

    QoL will be assessed with the EORTC QLQ-C30, which contains 30 items. Each item is scored on a Likert scale ranging from 1 (not at all) to 4 (very much), except for the global QoL scale that ranges from 1 (very poor) to 7 (excellent). The item will be transformed into a global health status (GHS) scale, five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea-vomiting), and six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores will be converted to a 0-100 scale. Higher numerical scores on functional scales or the GHS scale indicate better QoL, while higher scores on symptom scales/items reflect a greater level of symptoms or problems.

  2. Changes in reported EORTC QLQ CIPN20 subscales

    Time frame: 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

    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.

Other outcomes

  1. Changes in hand grip test a grip ability test

    Time frame: 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

    In the Hand grip test, the hand grip strength is measured three times for each upper limb with a rest interval between each grip of the device handle. The grip ability test is a modification of the general hand function test based on daily activities.

Study contacts

Contact information is provided by the study sponsor or research team.

Iveta Selingerova, Ph.D.

CONTACT

[email protected]

+420543136720

Martina Lojova, Ph.D.

CONTACT

[email protected]

+420543136232

Sponsors and collaborators

Lead sponsor

Martina Lojova

Other

Registry information

Official study title

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

Acronym: CIPN

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 12, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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