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Recruiting NCT06823440

Prevention of CIPN Using Compressive Therapy

No phase Interventional CIPN in Adjuvant Breast Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compression using surgical gloves and compression knee socks.
Who it may be relevant to
Registry conditions: CIPN in Adjuvant Breast Cancer Patients. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Device Compression using surgical gloves and compression knee socks
    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 deter

Primary outcome measures

  • Changes in reported EORTC QLQ CIPN20 subscales [Time frame: Before paclitaxel course (baseline) and completion paclitaxel course (standardly 12 weeks)]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Czechia · 1 center
  • Masaryk Memorial Cancer Institute — Brno

Identifiers

NCT: NCT06823440 · MOU-2024-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗