Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)

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.