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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Palmar-Plantar Erythrodysesthesia, Breast Cancer

In brief

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.

Key facts

Study ID

NCT01100463

Run by

Nanometics (d.b.a. PHD Biosciences)

People needed

18

Starts

2010-04-01

Expected to finish

2011-09-01

Last updated by the study team

2019-10-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Bruno Cancer Center — Birmingham, Alabama, United States
• Comprehensive Cancer Center — Palm Springs, California, United States
• Research Institute of Deaconess Clinic — Evansville, Indiana, United States
• Cancer Care Center — New Albany, Indiana, United States
• Kansas City Cancer Centers — Overland Park, Kansas, United States
• Signal Point Clinical Research Center — Middleton, Ohio, United States

Full record on ClinicalTrials.gov

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