Clinical trial · Interventional
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
NCT00245050CI-TRIAL-00005986completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin HCL liposome | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| pyridoxine hydrochloride | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pyridoxine
- description
- Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
- interventionNames
- Dietary Supplement: pyridoxine hydrochloride
- Drug: doxorubicin HCL liposome
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo twice 100 mg daily on days 1-28.
- interventionNames
- Drug: Placebo
- Drug: doxorubicin HCL liposome
Primary outcomes (1)
- measure
- Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Recurrent ovarian, fallopian tube, or peritoneal cavity cancer * Metastatic breast cancer * Advanced endometrial cancer * Planning to receive chemotherapy with doxorubicin HCl liposome at a dose of 40 mg/m\^2 * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Not specified Menopausal status: * Not specified Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * AST and ALT ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * Bilirubin normal Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram * No history of cardiac disease * No New York Heart Association class II-IV heart disease * No clinical evidence of congestive heart failure Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No active infection requiring antibiotics * No history of hypersensitivity reaction attributed to a conventional formulation of doxorubicin HCl or doxorubicin HCl liposome and any of its components * No other invasive malignancy within the past 5 years except nonmelanoma or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior biologic or immunologic agents for this cancer Chemotherapy * Recovered from prior chemotherapy * Alopecia or neuropathy allowed * No prior doxorubicin HCl liposome * Other concurrent chemotherapy allowed provided palmar-plantar erythrodysesthesia is not one of the side effects of the therapy * No concurrent cytarabine, fluorouracil, liposomal daunorubicin, or capecitabine * No concurrent pre-medication with corticosteroids as part of the chemotherapy regimen Endocrine therapy * See Chemotherapy * At least 3 weeks since prior and no concurrent oral or topical corticosteroids * At least 1 week since prior hormonal therapy for this cancer * Concurrent hormone replacement therapy allowed Radiotherapy * At least 3 weeks since prior radiotherapy for this cancer and recovered Surgery * Recovered from prior surgery Other * At least 3 weeks since prior and no other concurrent forms of pyridoxine except what is included in a multivitamin * No prior anticancer treatment that contraindicates study treatment * No concurrent amifostine or other protective agents
References
Publications (0)
Data not yet available
No reference posted for this study.