Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

In brief

RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome. PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving liposomal doxorubicin for recurrent ovarian, fallopian tube, or peritoneal cancer, metastatic breast cancer, or advanced endometrial cancer.

Key facts

Study ID

NCT00245050

Run by

Case Comprehensive Cancer Center

People needed

34

Starts

2004-04-01

Expected to finish

2011-09-01

Last updated by the study team

2011-12-30

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

Where it is running

• Geauga Regional Hospital — Cleveland, Ohio, United States
• Lake/University Ireland Cancer Center — Cleveland, Ohio, United States
• Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Southwest General Health Center — Cleveland, Ohio, United States
• University Suburban Health Center — Cleveland, Ohio, United States
• UHHS Westlake Medical Center — Cleveland, Ohio, United States
• Mercy Cancer Center at Mercy Medical Center — Cleveland, Ohio, United States
• UHHS Chagrin Highlands Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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