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Completed

NCT Number: NCT00213993

Topical Antiperspirant for Hand-Foot Syndrome

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.

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Key information

Conditions

Palmar-Plantar Erythrodysesthesia Chemically-Induced Disorders Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hand-Foot Syndrome Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antiperspirant

Drug

antiperspirant topically once daily to one foot

Primary outcomes

  1. reduction in palm and/or sole pain

    Time frame: after each of first four cycles of chemotherapy

Secondary outcomes

  1. evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES)

    Time frame: after each of first four cycles of chemotherapy

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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