NCT04833998

Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine

Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine: TACX Care Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Instituto Brasileiro de Controle do Cancer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hand-foot Syndrome

Interventions

Type	Name	Description
DRUG	Extremecare	The product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy.
DRUG	Placebo	Placebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy.

Timeline

• Start date: 2019-08-02
• Primary completion: 2021-11-30
• Completion: 2021-12-31
• First posted: 2021-04-06
• Last updated: 2021-04-06

Locations

1 site across 1 country: Brazil