Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this research study is to see if combining uracil cream (UTC) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects UTC and capecitabine may have in patients with metastatic breast cancer.

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Detailed Description

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Capecitabine is used in the treatment of human breast cancer among other human cancers. Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness and cracking of hands and feet. Currently, there are no approved therapies for HFS.

Conditions

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Palmar-Plantar Erythrodysesthesia Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Lotion

Group Type PLACEBO_COMPARATOR

Cream

Intervention Type DRUG

Twice daily lotion to prevent HFS

0.1% Uracil

Group Type EXPERIMENTAL

0.1% Uracil Cream

Intervention Type DRUG

Twice daily lotion to prevent HFS

Interventions

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Cream

Twice daily lotion to prevent HFS

Intervention Type DRUG

0.1% Uracil Cream

Twice daily lotion to prevent HFS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females, at least 18 years old
* Histologically or cytologically confirmed metastatic breast cancer
* You also cannot have any ulcerations or open wounds on palms of hands or soles of feet

Exclusion Criteria

* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier.
* Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches.

The above is not a complete list of eligibility criteria. Please see your study doctor for more information.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No