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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| C - no compression | No Intervention | Nonrandomized control group with no compression intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Lojova, Ph.D. | Contact | +420543136232 | martina.lojova@mou.cz | |
| Iveta Selingerova, Ph.D. | Contact | +420543136720 | iveta.selingerova@mou.cz |
| Name | Affiliation | Role |
|---|---|---|
| Tatiana Ciprova, MBA | Masaryk Memorial Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masaryk Memorial Cancer Institute | Recruiting | Brno | 60200 | Czechia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 | 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), after the sixth cycle of paclitaxel (standardly 6 weeks), after completion paclitaxel course (standardly 12 weeks) and six months after completition paclitaxel course |
| D017437 |
| Skin and Connective Tissue Diseases |