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

ConditionHFS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWooshin Labottach Co., Ltd.

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

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wooshin Labottach Co., Ltd.

Lead sponsor

Nextrasearch S.r.l.s.

Collaborator