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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.
lenitive cream
Device
Patients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Experimental deviceExperimental treatment 1 intervention

Group B: Lenitive creamActive comparator 1 intervention

Trial outcomes

Primary outcomes

Adverse events number

Number of Adverse events during the treatment

Time frame

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.

Time frame

3 weeks, from beginning to end of the trial

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wooshin Labottach Co., Ltd.

Lead sponsor

Nextrasearch S.r.l.s.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: