Status:
UNKNOWN
Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine
Lead Sponsor:
Instituto Brasileiro de Controle do Cancer
Collaborating Sponsors:
Wecare Comércio de Cosméticos
Conditions:
Hand-foot Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treatme...
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 moistur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04833998
Start Date
August 2 2019
End Date
December 31 2021
Last Update
April 6 2021
Active Locations (1)
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1
IBCC Oncologia
São Paulo, Brazil, 03102002