TerminatedPhase 2

The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients

Stopped: It is no longer practicable to complete the trial

Germany2 participantsStarted 2017-07-10

Plain-language summary

Comparative analysis of the severity of Hand-Foot-Syndrome (HFS) of palms treated with brimonidine tartrate gel or with standard care Urea 10% containing lotion in cancer patients receiving antineoplastic therapy to show a preventive effect of cutaneous brimonidine treatment on severity of HFS symptoms.

Who can participate

Age range

18 Years – 65 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: * Cancer patients with solid tumors under antineoplastic therapy with capecitabine or pegylated liposomal doxorubicin. * Patients with a life expectancy of at least 12 weeks. * History of HFS (grades 2 to 3) in the course of the therapy * Patients who are 18-65 years old. * Regression of HFS to grade 1 or lower with a symmetrical grading on both hands (grade 0 or grade 1) prior to the next cycle of chemotherapy. * not legally incapacitated * Written informed consent from the trial subject has been obtained. * Current treatment with capecitabine or pegylated liposomal doxorubicin Exclusion Criteria: * Persons with any kind of dependency on the investigator or employed by the sponsor or investigator. * Persons held in an institution by legal or official order. * Participation in other interventional trials * Drug \& substance abuse * Use of central nervous depressants (e.g. alcohol, barbiturates, opiates, sedatives or anaesthetics) * Patients taking alpha adrenergic agonists as medication. * Pregnant women and nursing mothers * Failure to use highly-effective contraceptive methods The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly effective: * Oral hormonal contraception ('pill') * Vaginal hormonal contraception (NuvaRing®) * Contraceptive plaster * Long-acting injectable contraceptives * Implants that release progesterone (Implanon®) * Tubal ligation (female sterilization) * Intrauterine devices that release hor…

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

Number and time of occurence of Palms with HFS severity grade 2 or 3

Timeframe: weekly up to 6 weeks

Trial details

NCT IDNCT03173365

SponsorHeinrich-Heine University, Duesseldorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

View on ClinicalTrials.gov More Hand-foot Syndrome trials