Randomized controlled trial comparing skin-moisturizing agents plus pyridoxine hydrochloride with skin-moisturizing agents alone to prevent hand-foot syndrome in patients received chemotherapy of capecitabine.

UMIN ID: UMIN000002030

Registered date:16/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2009/10/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

skin-moisturizing agents Grade0-1:heparinoid-containing soft ointment (w/o type) Grade=>1:heparinoid-containing soft ointment (w/o type) or 10% urea-containing soft ointment (w/o type) Patients receive skin-moisturizing agents applied to palms and soles 5 times daily.
pyridoxine hydrochloride

Outcome(s)

• Primary Outcome: Percentage of patients with Grade->2 hand-foot sydrome
• Secondary Outcome: Time to the Onset of Grade=>2 hand-foot syndrome Percentage of patients with Grade=1 hand-foot syndrome

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) Patients with pervious hypersensitive reactions to component 2) regular use of pyridoxine hydrochloride 3)Regular use of levodopa 4) Patients with Grade 1 or higher hand-foot syndrome 5) Patients received chemotherapy including 5Fu 6) Patients judged as the exclusive case by the investigator

Related Information

• Primary Sponsor: Shikoku Cancer Center
• Source(s) of Monetary Support: Policy-Based Medical Survices Foundation