NCT00213993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 5, 2015

Status Verified

December 1, 2007

Enrollment Period

1.4 years

First QC Date

September 13, 2005

Last Update Submit

October 1, 2015

Conditions

Palmar-plantar Erythrodysesthesia

Outcome Measures

Primary Outcomes (1)

  • reduction in palm and/or sole pain

    after each of first four cycles of chemotherapy

Secondary Outcomes (1)

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

    after each of first four cycles of chemotherapy

Study Arms (1)

A

EXPERIMENTAL

antiperspirant topically to one foot once daily

Drug: antiperspirant

Interventions

antiperspirantDRUG

antiperspirant topically once daily to one foot

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has not previously received a regimen that includes 5-fluorouracil
  • \> 18 years old
  • No known allergy or intolerance to Ban Unscented Roll-On Antiperspirant

You may not qualify if:

  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Antiperspirants

Condition Hierarchy (Ancestors)

Drug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

CosmeticsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Paul R Hutson, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2006

Study Completion

January 1, 2007

Last Updated

October 5, 2015

Record last verified: 2007-12

Locations

US(1)