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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Capecitabine for Breast and/or Other Cancer (Treatment Arms I-IV Closed to Accrual as of 10/25/2007)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI, Pharmaceutical / Industry	NCCTG-N05C5 ROCHE-NCCTG-N05C5, NCT00296036

Trial Description

Purpose:

Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome.

This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of six treatment groups.

Patients in group one will apply a urea/lactic acid-based cream to the palms of the hands and soles of the feet twice a day. They will also receive pyridoxine by mouth once a day for 3 weeks.

Patients in group two will apply a urea/lactic acid-based cream to the palms of the hands and soles of the feet twice a day. They will also receive a placebo by mouth once a day for 3 weeks.

Patients in group three will apply a placebo cream to the palms of the hands and soles of the feet twice a day. They will also receive pyridoxine by mouth once a day for 3 weeks.

Patients in group four will apply a placebo cream to the palms of the hands and soles of the feet twice a day. They will also receive a placebo by mouth once a day for 3 weeks.

Patients in group five will apply a urea/lactic acid-based cream to the palms of the hands and soles of the feet twice a day for 3 weeks.

Patients in group six will apply a placebo cream to the palms of the hands and soles of the feet twice a day for 3 weeks.

In all groups, treatment may repeat for up to four courses.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Jeffrey Berenberg, MD, Protocol co-chair		Ph: 808-586-3010

Registry Information
Official Title		A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome
Trial Start Date		2006-06-23
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00296036
Date Submitted to PDQ		2006-01-09
Information Last Verified		2009-01-23
NCI Grant/Contract Number		CA37404

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