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

Phase 3

Completed

• Conditions: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
• Interventions: Dietary Supplement: pyridoxine hydrochloride; Drug: Placebo; Drug: doxorubicin HCL liposome

• Registration Number: NCT00245050
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* Compare the efficacy of pyridoxine vs placebo in preventing palmar-plantar erythrodysesthesia (PPE) in patients receiving doxorubicin HCl liposome for recurrent ovarian, fallopian tube, or peritoneal cavity cancer, metastatic breast cancer, or advanced endometrial cancer.

* Compare quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind study. Patients are stratified according to cancer type (ovarian, fallopian tube, or peritoneal cavity cancer vs breast cancer vs endometrial cancer). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.

* Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.

In both arms, treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who develop grade 2-3 palmar-plantar erythrodysesthesia despite dose reduction of doxorubicin HCl liposome are unblinded and removed from the study (for patients in arm I) OR receive oral pyridoxine twice daily beginning day 1 of the next planned therapy (for patients in arm II).

Quality of life is assessed at baseline and after every third course of therapy.

After completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-27
• Primary Completion: 2008-04
• Results First Submitted: 2010-10-26
• Results First Submitted QC: 2010-11-29
• Results First Posted: 2010-12-22
• Study Completion: 2011-09
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-28
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pyridoxine	pyridoxine hydrochloride	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.
Pyridoxine	doxorubicin HCL liposome	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.
Placebo	Placebo	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.
Placebo	doxorubicin HCL liposome	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)	Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)	After Cycle 3 of chemotherapy (on average at 3 months)	QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL.

Trial Locations

Locations (8)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

University Suburban Health Center; 🇺🇸 Cleveland, Ohio, United States

Geauga Regional Hospital; 🇺🇸 Cleveland, Ohio, United States

Lake/University Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Mercy Cancer Center at Mercy Medical Center; 🇺🇸 Cleveland, Ohio, United States

UHHS Westlake Medical Center; 🇺🇸 Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center; 🇺🇸 Cleveland, Ohio, United States

Southwest General Health Center; 🇺🇸 Cleveland, Ohio, United States