Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-02-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A - compression short
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.
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 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.
B - compression long
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.
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 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.
C - no compression
Nonrandomized control group with no compression intervention.
No interventions assigned to this group
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent.
* Breast cancer stages I-III
* ECOG performance status 0-2.
* (Neo)adjuvant treatment with paclitaxel weekly.
Exclusion Criteria
* 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.
18 Years
70 Years
FEMALE
No
Sponsors
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Martina Lojova
OTHER
Responsible Party
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Martina Lojova
Tatiana Ciprova, lead nurse, Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
Principal Investigators
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Tatiana Ciprova, MBA
Role: PRINCIPAL_INVESTIGATOR
Masaryk Memorial Cancer Institute
Locations
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Masaryk Memorial Cancer Institute
Brno, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MOU-2024-03
Identifier Type: -
Identifier Source: org_study_id
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