Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: Pilot Randomized Controlled Trial
NCT ID: NCT05755646
Last Updated: 2024-05-24
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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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-03-10
2024-05-02
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
SINGLE
Study Groups
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Ice Plant Intensive Cream plus Standard Care
This group receives a 30-minute nursing consultation on the standard treatment and on the use of the Ice Plant Intensive Cream for the prevention of hand-foot syndrome.
Ice Plant Intensive Cream plus Standard Care
This group receives a 30-minute nursing consultation on the standard treatment according to the guideline "Supportive Therapy" for hand-foot syndrome and on the use of the Ice Plant Intensive Cream for the prevention of hand-foot syndrome. The nursing consultation on the standard treatment includes recommended basic measures for the prophylaxis of hand-foot syndrome such as the avoidance of mechanical stress and chemical irritants. In addition, treatment of pre-existing skin conditions is recommended. Furthermore, prophylaxis with urea-containing cream (5-10%) should be applied several times a day.
Standard Care
This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome.
Standard Care
This group receives a 30-minute nursing consultation on the standard treatment according to the guideline "Supportive Therapy" for hand-foot syndrome. The nursing consultation includes recommended basic measures for the prophylaxis of hand-foot syndrome such as the avoidance of mechanical stress and chemical irritants. In addition, treatment of pre-existing skin conditions is recommended. Furthermore, prophylaxis with urea-containing cream (5-10%) should be applied several times a day.
Interventions
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Ice Plant Intensive Cream plus Standard Care
This group receives a 30-minute nursing consultation on the standard treatment according to the guideline "Supportive Therapy" for hand-foot syndrome and on the use of the Ice Plant Intensive Cream for the prevention of hand-foot syndrome. The nursing consultation on the standard treatment includes recommended basic measures for the prophylaxis of hand-foot syndrome such as the avoidance of mechanical stress and chemical irritants. In addition, treatment of pre-existing skin conditions is recommended. Furthermore, prophylaxis with urea-containing cream (5-10%) should be applied several times a day.
Standard Care
This group receives a 30-minute nursing consultation on the standard treatment according to the guideline "Supportive Therapy" for hand-foot syndrome. The nursing consultation includes recommended basic measures for the prophylaxis of hand-foot syndrome such as the avoidance of mechanical stress and chemical irritants. In addition, treatment of pre-existing skin conditions is recommended. Furthermore, prophylaxis with urea-containing cream (5-10%) should be applied several times a day.
Eligibility Criteria
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Inclusion Criteria
* Therapy with Doxorubicin and/or Docetaxel
* Karnofsky performance status scale \> 80
* Informed consent
Exclusion Criteria
* Intolerance or allergic reaction on at least one ingredient of Ice Plant Intensive Cream
* Already receiving chemotherapy
* Usage of Ice Plant Intensive Cream before trial
* Severe physical or psychological illness due to which the patient is not able to participate in the study
* Lack of German language skills
18 Years
FEMALE
No
Sponsors
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Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
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Locations
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Robert-Bosch-Hospital
Stuttgart, , Germany
Countries
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Other Identifiers
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S00748-NIM
Identifier Type: -
Identifier Source: org_study_id
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