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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.