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Topical Antiperspirant for Hand-Foot Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00213993
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Palmar-plantar Erythrodysesthesia Drug: antiperspirant Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine
Study Start Date : May 2005
Primary Completion Date : October 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: A
antiperspirant topically to one foot once daily
Drug: antiperspirant
antiperspirant topically once daily to one foot



Primary Outcome Measures :
  1. reduction in palm and/or sole pain [ Time Frame: after each of first four cycles of chemotherapy ]

Secondary Outcome Measures :
  1. evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES) [ Time Frame: after each of first four cycles of chemotherapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00213993     History of Changes
Other Study ID Numbers: 2002-0487
CC-02308
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: December 2007

Additional relevant MeSH terms:
Hand-Foot Syndrome
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders