Clinical trial NCT06823440: Prevention of CIPN Using Compressive Therapy
Official title: Prevention of Chemotherapy-induced Polyneuropathy (CIPN) Using Compressive Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CIPN in Adjuvant Breast Cancer Patients
Keywords: CIPN
breast cancer
compressive therapy
chemotherapy
Lead sponsor: Masaryk Memorial Cancer Institute
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Changes in reported EORTC QLQ CIPN20 subscales
timeFrame: Before paclitaxel course (baseline) and completion paclitaxel course (standardly 12 weeks)
Secondary outcomes:
measure: Changes in reported EORTC QLQ-C30 subscales
timeFrame: 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
measure: Changes in reported EORTC QLQ CIPN20 subscales
timeFrame: 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:
measure: Changes in hand grip test a grip ability test
timeFrame: 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
Locations:
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
Study officials:
affiliation: Masaryk Memorial Cancer Institute
name: Tatiana Ciprova, MBA
role: PRINCIPAL_INVESTIGATOR
References: