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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01100463

Public ClinicalTrials.gov record NCT01100463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 7:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Topical Cream (UTC) in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01100463
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
18 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2010 (Actual)
Primary completion
Aug 2011 (Actual)
Completion
Sep 2011 (Actual)
Last update posted
Oct 8, 2019

2010 – 2011

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Bruno Cancer Center Birmingham Alabama 35205 —
Comprehensive Cancer Center Palm Springs California 92262 —
Research Institute of Deaconess Clinic Evansville Indiana 47713 —
Cancer Care Center New Albany Indiana 47150 —
Kansas City Cancer Centers Overland Park Kansas 66210 —
Signal Point Clinical Research Center Middleton Ohio 45042 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01100463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 8, 2019 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01100463 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →