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.

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. - 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002030

Enrollment

Registered

2009-06-16

Start date

2009-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

skin-moisturizing agents Grade0-1:heparinoid-containing soft ointment (w/o type) Grade=&gt

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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Age: At least 20 years of age 2) Patients with recurrent and advanced breast cancer 3) ECOG performance status:0-1 4) Patients without severe dysfunction of major organs a) T-Bil <=1.5mg/dl b) AST(GOT)/ALT(GPT) <=100IU/l c) Patients with liver metastatis:AST(GOT)/ALT(GPT) <=200U/l d) creatinine clearance =>50ml/min 5) Patients must have signed informed concent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Percentage of patients with Grade->2 hand-foot sydrome	—

Secondary

Measure	Time frame
Time to the Onset of Grade=>2 hand-foot syndrome Percentage of patients with Grade=1 hand-foot syndrome	—

Countries

Japan

Contacts

Public ContactKazuo Komatsubara

Shikoku Cancer Center Department of Hospital Pharmacy

089-999-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026