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| Name | Class |
|---|---|
| Nextrasearch S.r.l.s. | OTHER |
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The goal of this clinical trial is to learn if The Uracil plaster works to treat mild HFS in adults under chemiotherapy. It will also learn about the safety .
The main questions it aims to answer are:
Does Uracil Plaster lower the number of days participants need to reduce the HFS symptoms? What medical problems do participants have when using the Uracil plaster MD? Researchers will compare the Uracil plaster to a standard lenitive cream to see if Uracil Plaster works better to treat mild HFS.
Participants will:
Use the plaster or the cream 2/3 times day for 3 weeks Visit the hospital once every week for checkups and tests Keep a diary of their symptoms and the number of times they use the therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental device | Experimental | Patients will applicate Uracil plasters twice per day for 3 weeks |
|
| Lenitive cream | Active Comparator | Patients will applicate Lenitive cream 3 times per day for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uracil 0,5% plasters | Device | Patients will applicate to hands and feet the plaster twice per day for 3 weeks to reduce the HFS grade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events number | Number of Adverse events during the treatment | 3 weeks, from the start to the end of the trial |
| Complete healing of the lesions according to HFS severity scale | Complete healing of the hands or feet lesions without chemotherapy dosage reduction, using HFS severity scales to assess the absence of symptoms. | 3 weeks, from beginning to end of the trial |
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Inclusion Criteria
Exclusion criteria
Patients with grade III severity according to of HFS severity (Hand-Foot Syndrome- NCI-CTCAE v.0 Severity Grading.
ECOG Performance Status Scale = 3 or 4
Pregnancy (applicable only to non-menopausal female subjects);
Breastfeeding (applicable only to non-menopausal female subjects);
Non-menopausal female subjects not using the specified contraceptive measures to prevent pregnancy during the study;
Sensitivity or allergy to the investigational product or its components (to be assessed by the investigator at baseline);
Predicted poor compliance with study protocol;
Participation in a similar study currently or within the past 3 months;
Dermatological clinical conditions that could interfere with performance outcomes;
Current pharmacological treatment with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Bollina, Prof. | Contact | +39 3356070900 | rbollina@asst-rhodense.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidio Ospedaliero Di Rho - Asst Rhodense- Oncology Department | Rho | MI | 20017 | Italy |
The trial results will be published on scientific paper
as soon as available, w/o time limits.
potentially all the medical class
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Monocentric, two arms (experimental device vs. standard lenitive cream), single blind interventional study
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| lenitive cream | Device | Patients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity |
|