Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome
- Registration Number
- NCT01097850
- Lead Sponsor
- Northwestern University
- Brief Summary
The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
- New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
- Patients must be 18 years or older
- Patients must provide written informed consent to participate in the study
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Exclusion Criteria
- Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
- Known allergy to natural henna
- Patients with a previous history of HFS
- History of G6PD deficiency as determined by screening bloodwork
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Right henna paste Application of henna paste to right hand/foot plus CeraVe moisturizer Left henna paste Application of henna paste to the left hand/foot plus CeraVe moisturizer
- Primary Outcome Measures
Name Time Method • To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side. 3 weeks
- Secondary Outcome Measures
Name Time Method To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire 3 weeks