HFS
Conditions
Keywords
Uracil, uracil plaster, HFS, HFS in oncologic patients
Brief summary
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
Interventions
DEVICEUracil 0,5% plasters
Patients will applicate to hands and feet the plaster twice per day for 3 weeks to reduce the HFS grade.
DEVICElenitive cream
Patients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity
Sponsors
Wooshin Labottach Co., Ltd.
Nextrasearch S.r.l.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Monocentric, two arms (experimental device vs. standard lenitive cream), single blind interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both sexes; * Aged over 18 years; * Willing and able to return to the study site for post-procedural assessments; * Agree to take precautions to prevent pregnancy (applicable only to non-menopausal female subjects), including abstinence, intrauterine device (IUD), progestin implants, combined estrogen-progestin contraceptives, or condom use; * Agree to sign the informed consent form. * With HFS of grade I and II severity due to chemotherapy Self-sufficient with Performance Status of 0, 1, 2 according with the EOCG table. * Red blood cells folate test and serum folate test- Independent Biomarkers performed and to polymorphism testing DPD before starting therapy with dihydro pyrimidines.
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: * Medications that may affect test results as deemed by the investigator. * Use of other medications not mentioned above can be authorized by the investigator. Trade name, dosage, start and end dates of therapy will be documented in the concomitant medication form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events number | 3 weeks, from the start to the end of the trial | Number of Adverse events during the treatment |
| Complete healing of the lesions according to HFS severity scale | 3 weeks, from beginning to end of the trial | Complete healing of the hands or feet lesions without chemotherapy dosage reduction, using HFS severity scales to assess the absence of symptoms. |
Countries
Italy
Contacts
CONTACTRoberto Bollina, Prof.
Outcome results
None listed