The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients (BRIMOCAN)
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|ClinicalTrials.gov Identifier: NCT03173365|
Recruitment Status : Terminated (It is no longer practicable to complete the trial)
First Posted : June 1, 2017
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hand-foot Syndrome||Drug: Brimonidine Tartrate||Phase 2|
Hand-foot syndrome (HFS) is an adverse event frequently associated with the use of classical chemotherapeutic agents such as capecitabine or pegylated liposomal doxorubicin, as well as targeted cancer drugs such as sorafenib or other tyrosine-kinase inhibitors. If the toxicity progresses edematous swelling, blistering and desquamation can lead to ulcerations of the palms and soles. Additionally, patients may be affected by nail-toxicities, such as discoloration, ridging, pitting up to complete onycholysis and pain. Today, cooling of hands and feet during infusion chemotherapy as well as preventive treatment with topical formulations containing urea 10% (e.g. Excipial U10 Lipolotion®) is considered as standard of care. Yet, these strategies are limited by intricateness, patient inconvenience and low efficacy. Hence, at this point the satisfactory treatment of HFS remains an unmet medical need, as until now, no effective therapy is available to prevent or reduce HFS symptoms during the cycle of chemotherapeutic treatment.
Recently, brimonidine 3 mg/g gel (Mirvaso®) has been approved as a topical treatment of facial erythema of rosacea in adult patients. Brimonidine is an effective agonist of α2-adrenoreceptors thereby, in analogy to skin cooling, leading to peripheral vasoconstriction.
Against this background, the following hypothesis was developed:
The topical application brimonidine 3 mg/g gel (Mirvaso®) may prevent or reduce the severity of HFS in cancer patients that receive respective antineoplastic agents.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The respective palm to be treated will be randomly assessed and will be matched for handedness to include equal numbers of dominant and non‐dominant treated palms.|
|Masking:||None (Open Label)|
|Official Title:||Half‐Side Controlled Analysis of the Effect of Topical Brimonidine Tartrate on the Frequency and Severity of Hand‐Foot Syndrome (HFS) in Cancer Patients Receiving Antineoplastic Agents (BRIMOCAN)|
|Actual Study Start Date :||July 10, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Brimonidine Tartrate
The respective palm to be treated with Brimonidine will be randomly assessed and will be matched for handedness to include equal numbers of dominant and non‐dominant treated palms.
Drug: Brimonidine Tartrate
1 gram of Brimonidine 3 mg/g gel (Mirvaso®) in 24 hours on the randomized palm equal to a finger tip unit (FTU) of 0.5 gram , topical application under occlusion twice per day, every 12 hours.
Other Name: Mirvaso
- Number and time of occurence of Palms with HFS severity grade 2 or 3 [ Time Frame: weekly up to 6 weeks ]Palms with HFS severity of grade 2 or 3 during 2 cycles of chemotherapy or over 6 week period by means of the National Cancer Institute Common Terminology criteria for Adverse Events (NCI‐CTCAE) v4.0 grading
- NCI-CTCAE v4.0 grading of HFS severity [ Time Frame: weekly up to 6 weeks ]Severity of HFS after 2 cycles of chemotherapy or 6 weeks by means of the NCI‐CTCAE v4.0 grading
- Severity of nail toxicity [ Time Frame: weekly up to 6 weeks ]Severity of nail toxicity after 2 cycles of chemotherapy or 6 weeks by means of the NCI‐CTCAE v3.0 grading
- modified ppPASI grading of HFS severity [ Time Frame: weekly up to 6 weeks ]Severity of HFS after 2 cycles of chemotherapy or 6 weeks by means of a modified Palmoplantar Psoriasis Area Severity Index (ppPASI)
- computer-assisted quantification of HFS severity [ Time Frame: weekly up to 6 weeks ]Severity of HFS after 2 cycles of chemotherapy or 6 weeks by means of computer‐assisted quantification
- HFS associated pain (by VAS scale) [ Time Frame: weekly up to 6 weeks ]Level of HFS‐associated pain after 2 cycles of chemotherapy or 6 weeks by means of visual analogue scale (VAS)
- Highest grade of HFS severity (NCI-CTCAE v4.0 grading) [ Time Frame: weekly up to 6 weeks ]Highest grade of HFS severity reached until 2 cycle of chemotherapy or over 6 week period by means of the NCI‐CTCAE v4.0 grading
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173365
|Universitätsklinikum Düsseldorf, Klinik für Dermatologie|
|Düsseldorf, Germany, 40225|
|Principal Investigator:||Peter Arne Gerber, PD Dr. med.||Heinrich-Heine University, Duesseldorf|