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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00245050

Public ClinicalTrials.gov record NCT00245050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 9:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00245050
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
34 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2004 (Type not available)
Primary completion
Apr 2008 (Actual)
Completion
Sep 2011 (Actual)
Last update posted
Dec 30, 2011

2004 – 2011

United States locations

U.S. sites
8
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Geauga Regional Hospital Cleveland Ohio 44024 —
Lake/University Ireland Cancer Center Cleveland Ohio 44060 —
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio 44106-5065 —
Southwest General Health Center Cleveland Ohio 44130 —
University Suburban Health Center Cleveland Ohio 44143 —
UHHS Westlake Medical Center Cleveland Ohio 44145 —
Mercy Cancer Center at Mercy Medical Center Cleveland Ohio 44708 —
UHHS Chagrin Highlands Medical Center Cleveland Ohio 44708 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00245050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 30, 2011 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00245050 live on ClinicalTrials.gov.

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