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

Hand-foot Syndrome Clinical Trial

— TACX Care  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833998
• Other study ID #: 01629018.1.0000.0072
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Flavia Viécili Tarcha, MD
• Phone: +55 11 99700-0316
• Email: flavinhavt[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female =18 years of age
• Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine
• Indication of adjuvant or palliative treatment with capecitabine
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Information of the patient and signature of the informed consent form by the patient or her legal representative.

Exclusion Criteria:

• Previous chemotherapy with capecitabine
• Pre-existing patients with neuropathies
• Patients with known allergic reactions to any of the ingredients of the investigational product
• Patients with dermatological conditions that affect the hands or feet
• Patients with rectal neoplasia and indication for neoadjuvant treatment.

Related Conditions & MeSH terms

• Hand-foot Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	IBCC Oncologia	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer	Wecare Comércio de Cosméticos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.	Number of Patients who developed Hand-foot Syndrome (HFS) by Toxicity Grade. The incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 for all patients assigned who received at least 1 cycle of capecitabine. Investigators assess and fill the grading into the case report form every visit.	Up to 15 weeks
Secondary	Changes in the signs of hand-foot syndrome	Digital Photos will be taken of the hands and feet at 21 day intervals until the fifth cycles of capecitabine-containing chemotherapy ended to evaluate Erythema, desquamation, edema, ulceration, vesicopustules.	Baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)
Secondary	Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.	Determined by the number of patients who required a toxicity-related, dose reduction of capecitabine during active treatment at each cycle where a dose reduction occurred	Up to 15 weeks
Secondary	Quality of Life as Measured by Dermatology Life Quality Index (DLQI)	Dermatology Life Quality Index (DLQI) consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. It is self explanatory and is usually completed in one or two minutes.	Up to 15 weeks
Secondary	Incidence of cessation of capecitabine therapy	Cessation of capecitabine thereby because any toxicity	Up to 15 weeks