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Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

NCT ID: NCT01097850

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-01-31

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.

Detailed Description

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Conditions

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Hand Foot Skin Syndrome

Keywords

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hand foot skin syndrome palmar plantar erythrodysesthesia doxorubicin capecitabine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Right

Application of henna paste to right hand/foot plus CeraVe moisturizer

Group Type OTHER

henna paste

Intervention Type DRUG

Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet

Left

Application of henna paste to the left hand/foot plus CeraVe moisturizer

Group Type OTHER

henna paste

Intervention Type DRUG

Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet

Interventions

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henna paste

Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Dennis West

Professor in Dermatology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Lio, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Countries

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United States

Other Identifiers

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NU 09D1

Identifier Type: -

Identifier Source: org_study_id