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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Case Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00245050

First received: October 25, 2005

Last updated: December 28, 2011

Last verified: December 2011

History of Changes

Results First Received: October 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Supportive Care
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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the outpatient gynecologic oncology clinics at University Hospitals from May 2004 to December 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were required to have discontinued corticosteroid therapy at least three weeks prior to enrollment and no corticosteroids were allowed for the duration of the trial. Patients must have discontinued pyridoxine therapy at least three weeks prior to enrollment.

Reporting Groups

	Description
Pyridoxine	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.
Placebo	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.

Participant Flow: Overall Study

	Pyridoxine	Placebo
STARTED	18	16
COMPLETED	15	14
NOT COMPLETED	3	2
Adverse Event	3	2

Baseline Characteristics

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Reporting Groups

	Description
Pyridoxine	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.
Placebo	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.
Total	Total of all reporting groups

Baseline Measures

	Pyridoxine	Placebo	Total
Number of Participants [units: participants]	18	16	34
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	8	6	14
>=65 years	10	10	20
Age [units: years] Mean ± Standard Deviation	62.9 ± 9.4	65.9 ± 11.0	64.3 ± 10.2
Gender [units: participants]
Female	18	16	34
Male	0	0	0
Region of Enrollment [units: participants]
United States	18	16	34

Outcome Measures

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1. Primary:

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

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2. Secondary:

Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G) [ Time Frame: After Cycle 3 of chemotherapy (on average at 3 months) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Interim analysis was conducted after 30 patients were enrolled and had evaluable PPE assessment data. Due to decreased accrual and similar PPE rates between groups, the trial was closed for enrollment after the interim analyses was completed.

Results Point of Contact:

Name/Title: Vivian von Gruenigen, MD
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
phone: 216-844-5011
e-mail: vev1@case.edu

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00245050 History of Changes
Other Study ID Numbers:	CASE5Y03, P30CA043703, CASE5Y03
Study First Received:	October 25, 2005
Results First Received:	October 26, 2010
Last Updated:	December 28, 2011
Health Authority:	United States: Federal Government

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