Hand-Foot Syndrome
Conditions
Keywords
hand foot syndrome, capecitabine, urea cream
Brief summary
Hand foot skin reaction (HFS) from capecitabine is one of the most common adverse events from capecitabine. Urea cream has been proved its benefit to prevent HFS from sorafenib. Prior study using urea cream prophylaxis in patients receiving capecitabine was negative. However, result from aformentioned study was reported primarily from result of first cycle capecitabine. Urea cream as a prevention of HFS from capecitabine has been used in clinical practice in Thailand according to expert's opinion. We conducted the study to evaluate wheter the urea cream can prevent HFS or severe HFS.
Detailed description
The patients who is planned to receive capecitabine for at least 3 cycles were enrolled in the study. The patients were randomized to receive 10% urea cream or standard measure. The patients were followed until the end of capecitabine treatment. The patients reported their symptoms of HFS and other adverse events (AE) before starting new cycle of capecitabine. Physician record of HFS and other AE, dose modification of capecitabine and compliance were extracted. We will report incidence of any HFS, \> grade 3 HFS, capecitabine interruption or delay or discontinuation and time to develop HFS among both arms. The results of the study will be used for optimal prophylactic measures in patients treated with capecitabine.
Interventions
DRUGUrea cream
apply 10% urea cream at both hands and feet twice daily
Sponsors
Siriraj Hospital
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- patients who has plan to receive capecitabine at the dosage of at least 2000 mg/m2 D1-14 every 21 days for at least 3 cycles
Exclusion criteria
* preexisting neuropathy which was severe than grade 2 * history of allergy to urea cream * patients with previous use of capecitabine 2000 mg/m2 * patients who has prior routinely used of urea cream
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| any HFS | from starting capecitabine until 4 week after capecitabine discontinuation | incidence of any HFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severe HFS | from starting capecitabine until 4 week after capecitabine discontinuation | grade 3 or 4 HFS |
| time to develop severe HFS | from starting capecitabine until 4 week after capecitabine discontinuation | time for starting capecitabine to time of \>grade II HFS reported |
| capecitabine interruption | from starting capecitabine until 4 week after capecitabine discontinuation | proportion of patient with capecitabine interruption due to HFS |
Countries
Thailand
Contacts
Primary ContactSuthinee Ithimakin, MD
Outcome results
None listed