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| Name | Class |
|---|---|
| Siriraj Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | No Intervention | standard of care including hand and foot care, avoid friction | |
| urea cream | Experimental | use 10% urea cream apply at both hands and feet twice a day from time of starting capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urea cream | Drug | apply 10% urea cream at both hands and feet twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| any HFS | incidence of any HFS | from starting capecitabine until 4 week after capecitabine discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| severe HFS | grade 3 or 4 HFS | from starting capecitabine until 4 week after capecitabine discontinuation |
| time to develop severe HFS | time for starting capecitabine to time of >grade II HFS reported |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suthinee Ithimakin, MD | Contact | +6624194489 | aesi105@yahoo.co.th |
| Name | Affiliation | Role |
|---|---|---|
| Suthinee Ithimakin, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of medical oncology, department of medicine Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39962445 | Derived | Wongkraisri C, Chusuwanrak K, Laocharoenkeat A, Chularojanamontri L, Nimmannit A, Ithimakin S. Randomized controlled trial on the efficacy of topical urea-based cream in preventing capecitabine-associated hand-foot syndrome. BMC Cancer. 2025 Feb 17;25(1):275. doi: 10.1186/s12885-025-13684-1. |
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| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| from starting capecitabine until 4 week after capecitabine discontinuation |
| capecitabine interruption | proportion of patient with capecitabine interruption due to HFS | from starting capecitabine until 4 week after capecitabine discontinuation |
| D004342 |
| Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |