Not Yet RecruitingPhase 2

TAR-0520 Gel in Hand and Foot Syndrome

France25 participantsStarted 2026-03

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Advers events

Timeframe: Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days

Trial details

NCT IDNCT07457671

SponsorTarian Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Janusz M Czernielewski, MD

+33680338274 janusz.czernielewski@tarianpharma.com

View on ClinicalTrials.gov More Hand and Foot Syndrome trials