Hand Foot Skin Syndrome
Conditions
Keywords
hand foot skin syndrome, palmar plantar erythrodysesthesia, doxorubicin, capecitabine
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.
Interventions
DRUGhenna paste
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire | 3 weeks |
Outcome results
None listed