At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of recurrent ovarian, fallopian tube, or peritoneal cavity cancer; metastatic breast cancer; or advanced endometrial cancer
- ✓Planning to receive doxorubicin HCl liposome at 40 mg/m²
- ✓Karnofsky performance status 60-100%
- ✓Absolute neutrophil count ≥1,500/mm³
- ✕History of cardiac disease, NYHA class II-IV heart disease, or clinical evidence of congestive heart failure
- ✕Active infection requiring antibiotics
- ✕History of hypersensitivity reaction to conventional doxorubicin HCl or doxorubicin HCl liposome or any of its components
- ✕Other invasive malignancy within past 5 years, except nonmelanoma or basal cell skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
In Brief
A Phase 3 clinical trial evaluating pyridoxine hydrochloride, Placebo, and 1 other intervention for Breast Cancer and 5 related conditions. Completed, enrolled 34 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28.
Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
IV, 40mg/m2