TAR-0520 Gel in Hand and Foot Syndrome
ConditionHand and Foot Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarian Pharma
About this trial
Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on their daily activities.
The aim of this study is to explore the TAR-0520 gel safety and preventive efficacy of HFS in patients with colorectal and breast cancer patients treated with capecitabine.
Is the product well tolerated locally and systemically ? Is the product reducing frequency and severity of HFS ? Is product improving Quality of Life (QoL) of treated patients ? Each patient will receive the active TAR-0520 gel and they will apply it to both hands,twice daily. Applications will be done 1 hour before each morning and evening capecitabine oral intake.
Feet will be not treated and will serve as controls. In total , this study will follow patients during 4 capecitabine Cycles (each Cycle=21 days) for a total of 12 weeks.
Clinical evaluations will take place at Day1 of each Cycle and will be conducted separetaly on hands and feet.
Eligibility criteria
Qualifiers
Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine
at a dose > 1000mg/m² twice daily every 2 out of 3 weeks as single agent chemotherapy
Patients with life expectancy graeter than 12 weeks
Disqualifiers
Patient with medical history of capecitabine treatment
patient with pre-existing neuropathy confounding assessement of HFS
Patient with Raynaud's syndrome or other vascular peripheral disorders
Patient with dermatological lesions on hands or foot
Trial design
Treatments tested in this trial
- TAR-0520 gel
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov