About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Uracil 0,5% plasters
- lenitive cream
Treatment groups
Sponsors and collaborators
Wooshin Labottach Co., Ltd.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator