Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer - Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002932

Enrollment

150

Registered

2010-01-01

Start date

2010-01-01

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

Locally advanced or metastatic breast cancer

Interventions

No prodpxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy Pridoxine group: Patients receiving capecitabine mono therapy or capecitabine combination chem

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Diagnosis of advanced breast cancer 2. 20 years old or more 3. ECOG performance status 0-1 4. Can eat 5. Life expectancy more than 3 months 6. Written informed consents 7. Sufficient organ functions

Exclusion criteria

Exclusion criteria: 1. History of serious drug hypersensitivity or a history of drug allergy by fluoropyrimidine. History of adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase deficiency 2. Capecitabine used prior chemotherapy 3. History of drug hypersensitivity not suitable for this study 4. Uncontrolled serious complications 5. Multiple primary cancer within 5 years 6. Pregnant women or possibly pregnant women 7. Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Time to the onset of HFS (Grade2 or 3)	—

Secondary

Measure	Time frame
Incidence of HFS (any Grade) Time to the onset of HFS (any Grade) Incidence of HFS by chemotherapy type Treatment duration and dosage of Capecitabine administration Safety Quality of life by Skindex29 Finger pressure by pinch meter	—

Countries

Japan

Contacts

Public ContactKeiko Ohmori

Tokai Breast Cancer Clinical Research Group (TBCRG) Office

hiwata@aichi-cc.jp052-762-6111

Outcome results

None listed

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