Effect of Hilotherapy in the Management of Symptoms Related to Taxane-Associated Peripheral Neuropathy
NCT ID: NCT07345221
Last Updated: 2026-01-15
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
60 participants
INTERVENTIONAL
2025-06-04
2026-08-31
Brief Summary
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* The experimental and control group patients will answer the survey questions according to the data collection forms before the first chemotherapy course (To) and will undergo physical examinations by the researcher.
* In the experimental group, the Hilotherapy device will be connected and initiated 30 min before the chemotherap.
* The device will continue to cool for another 60 minutes when the chemotherapy ends.
* Both groups will continue to receive chemotherapy courses at the intervals determined as planned.
* Hilotherapy will be applied to the experimental group patients during each course according to the study protocol.
* For both groups, participants will answer the questions according to the data collection forms and will undergo physical examinations by the researcher after the 4th chemotherapy course (T1), 8th chemotherapy course (T2), 12th chemotherapy course (T3) and 4 weeks after the end of chemotherapy (T4).
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Detailed Description
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1. 30 minutes before chemotherapy, disposable cellulose covers are placed on the patient's clean hands and feet (for hygiene and to prevent contamination)
2. The device is set to 12°C for hands and 14°C for feet.
3. Sensors are monitored during chemotherapy.
4. The hylotherapy application is continued for another 60 minutes after the end of the chemotherapy course.
5. At the end of the period, the sleeves and disposable covers are removed.
Data Collection Tools of the Study
* Introductory Information Form (designed by the researchers)
* "Other Methods Used by the Patient to Prevent Peripheral Neuropathy" Form
* Hilotherapy Application Data Form
* LANSS Pain Scale
* European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
* European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Associated Peripheral Neuropathy Scale (EORTC QLQ-CIPN20)
* General Comfort Scale-Short Form
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Study Group
Hilotherapy
Hilotherapy
Applying hilotherapy device at chemotherapy courses
Control group
Non-hilotherapy
No interventions assigned to this group
Interventions
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Hilotherapy
Applying hilotherapy device at chemotherapy courses
Eligibility Criteria
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Inclusion Criteria
* Having received chemotherapy containing taxane compounds due to breast cancer
* Not having been previously diagnosed with peripheral neuropathy
Exclusion Criteria
* History of psychiatric disorder
* Diagnosed diseases such as diabetes mellitus, autoimmune disease, megaloblastic anemia, cervical/spinal disc herniation, Raynaud's
* Active lesions on hands or feet
* Bleeding/clotting disorder
* Extremity amputation
* Any problem that prevents cognitive, emotional and verbal communication
18 Years
ALL
No
Sponsors
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Nuran Ayşen Pamir Aksoy
OTHER
Responsible Party
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Nuran Ayşen Pamir Aksoy
Assist. Prof.
Locations
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Acibadem Altunizade Hospital
Istanbul, , Turkey (Türkiye)
Acibadem Maslak Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-13-470
Identifier Type: -
Identifier Source: org_study_id
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