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NCT00245050 · ClinicalTrials.gov registry record · Phase 3
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
A Phase 3 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT00245050: Completed Phase 3 study, sponsored by Case Comprehensive Cancer Center.
NCT00245050 is a Phase 3 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00245050, a Phase 3 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT pyridoxine hydrochloride
- DRUG doxorubicin HCL liposome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2004-04 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT00245050 record still lists
NCT00245050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00245050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00245050 about?
NCT00245050 is a clinical study titled "Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer". 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 compa...
What is the current status of trial NCT00245050?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2004-04. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00245050?
The interventions under investigation include: Placebo (DRUG), pyridoxine hydrochloride (DIETARY_SUPPLEMENT), doxorubicin HCL liposome (DRUG).
Who is sponsoring clinical trial NCT00245050?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00245050's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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