Testing the Effectiveness of Henna on Managing PPE

• Status: Completed
• Trial end date: 2018-06-15
• Target enrollment: 0
• Participant gender: All

Summary

The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity. this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyprus University of Technology
• Treatments: Capecitabine; Doxorubicin; Lawsone; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Adult cancer patients (>18)

• Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents

• Patients that will experience PPE grade 1 or above

• Willing to participate

• Ability to complete the psychometric assessments.

• A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG)

Exclusion Criteria:

• Patients with hypersensitivity to natural henna.

• Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results

• Patients on Pyridoxine or nicotine patches

• Patients with a previous history of PPE

• Patients whose chemotherapy was discontinued for more than a week