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Topical Antiperspirant for Hand-Foot Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00213993
First received: September 13, 2005
Last updated: December 21, 2007
Last verified: December 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 16, 2013