Palmar-plantar Erythrodysesthesia Clinical Trial
Official title:
Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | January 2007 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction in palm and/or sole pain | after each of first four cycles of chemotherapy | Yes | |
Secondary | evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES) | after each of first four cycles of chemotherapy | No |
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