The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients (NCT03173365) | Clinical Trial Compass
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 range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Number and time of occurence of Palms with HFS severity grade 2 or 3