Prevention of CIPN Using Compressive Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorMartina Lojova
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Metastatic disease.
History of neuropathy/vasculopathy and its pharmacological treatment.
Type I or II diabetes.
Stroke within the last 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Compression using surgical gloves and compression knee socks
DeviceCompression 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: A - compression shortExperimental treatment 1 intervention
Group B: B - compression longExperimental treatment 1 intervention
Group C: C - no compressionNo intervention 0 interventions
Trial outcomes
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.
Time frame
Before paclitaxel course (baseline) and completion paclitaxel course (standardly 12 weeks)Secondary outcomes
1
Changes in reported EORTC QLQ-C30 subscales
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.
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 course2
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.
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 courseOther outcomes
1
Changes in hand grip test a grip ability test
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.
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 courseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Martina Lojova
Lead sponsor
Masaryk Memorial Cancer Institute
Sponsor institution
Source ClinicalTrials.gov