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Clinical Trial Summary

Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL). The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS. It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome. The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.


Clinical Trial Description

The research product, proposed in this study, was developed to meet the specific hydration needs of patients undergoing cancer treatment and is produced from nine main ingredients with natural moisturizing actions based on glycerin, hazelnut extract, shea butter, aloe vera, calendula, chamomile and oat extract and 2 antioxidants (vitamin E and Thoitaine), dermatologically tested and approved. The choice of the product was based, mainly, due to its natural components, whose data from previous studies were extrapolated from radiodermatitis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04833998
Study type Interventional
Source Instituto Brasileiro de Controle do Cancer
Contact Flavia Viécili Tarcha, MD
Phone +55 11 99700-0316
Email flavinhavt@yahoo.com
Status Recruiting
Phase Phase 2
Start date August 2, 2019
Completion date December 31, 2021

See also
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Completed NCT00446147 - Study of Pyridoxine for Hand-Foot Syndrome Phase 3
Completed NCT01609166 - Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome Phase 2
Terminated NCT03173365 - The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients Phase 2
Recruiting NCT04979078 - Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction N/A
Recruiting NCT05165069 - The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome Phase 3
Recruiting NCT05348278 - Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome Phase 2/Phase 3
Not yet recruiting NCT05949307 - The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome N/A