Topical Antiperspirant for Hand-Foot Syndrome

Palmar-plantar Erythrodysesthesia Clinical Trial

Official title:

Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213993
• Other study ID #: 2002-0487
• Secondary ID: CC-02308
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 1, 2015
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand-Foot Syndrome
• Palmar-plantar Erythrodysesthesia

Intervention

Drug:
• antiperspirant
antiperspirant topically once daily to one foot

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

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