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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on October 23, 2014