Topical Antiperspirant for Hand-Foot Syndrome - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00213993

Purpose

The objectives of this study are to evaluate the effectiveness of an antiperspirant in preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with the Food and Drug Administration (FDA)-approved doses of capecitabine. The hypothesis is that cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing chronic toxicity.

Condition	Intervention	Phase
Palmar-Plantar Erythrodysesthesia	Drug: antiperspirant	Phase II

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

reduction in palm and/or sole pain [ Time Frame: after each of first four cycles of chemotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES) [ Time Frame: after each of first four cycles of chemotherapy ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	May 2005
Study Completion Date:	January 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental antiperspirant topically to one foot once daily	Drug: antiperspirant antiperspirant topically once daily to one foot

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has not previously received a regimen that includes 5-fluorouracil
> 18 years old
No known allergy or intolerance to Ban Unscented Roll-On Antiperspirant

Exclusion Criteria:

< 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213993

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Paul R Hutson, PharmD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin Comprehensive Cancer Center ( Paul Hutson, Pharm. D )
Study ID Numbers:	2002-0487, CC-02308
Study First Received:	September 13, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00213993 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Capecitabine

ClinicalTrials.gov processed this record on May 07, 2009