Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms

Conditions
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Hand Foot Skin Syndrome

Intervention / Treatment
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* Drug: henna paste


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Right<br>Application of henna paste to right hand/foot plus CeraVe moisturizer | Drug: henna paste<br>* Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet<br>|
| Other: Left<br>Application of henna paste to the left hand/foot plus CeraVe moisturizer | Drug: henna paste<br>* Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand foot skin syndrome, palmar plantar erythrodysesthesia, doxorubicin, capecitabine