CompletedNot Applicable

Testing the Effectiveness of Henna on Managing PPE

Cyprus56 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change from Baseline PPE Grade at 3,4, 5,6 weeks

Timeframe: 3, 4, 5 and 6 weeks

Trial details

NCT IDNCT01751893

SponsorCyprus University of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-01

View on ClinicalTrials.gov More Palmar-plantar Erythrodysesthesia (PPE) trials