Back to resultsTopical Antiperspirant for Hand-Foot Syndrome
Primary Purpose
Palmar-plantar Erythrodysesthesia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
antiperspirant
Sponsored by
About this trial
This is an interventional prevention trial for Palmar-plantar Erythrodysesthesia
Eligibility 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
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
antiperspirant topically to one foot once daily
Outcomes
Primary Outcome Measures
reduction in palm and/or sole pain
Secondary Outcome Measures
evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES)
Full Information
NCT ID
NCT00213993
First Posted
September 13, 2005
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00213993
Brief Title
Topical Antiperspirant for Hand-Foot Syndrome
Official Title
Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmar-plantar Erythrodysesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
antiperspirant topically to one foot once daily
Intervention Type
Drug
Intervention Name(s)
antiperspirant
Intervention Description
antiperspirant topically once daily to one foot
Primary Outcome Measure Information:
Title
reduction in palm and/or sole pain
Time Frame
after each of first four cycles of chemotherapy
Secondary Outcome Measure Information:
Title
evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES)
Time Frame
after each of first four cycles of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R Hutson, PharmD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Antiperspirant for Hand-Foot Syndrome
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