Eniluracil Hand Foot Syndrome (NCT00827580) | Clinical Trial Compass
TerminatedPhase 1
Eniluracil Hand Foot Syndrome
United States3 participantsStarted 2009-01
Plain-language summary
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed written informed consent.
. Male or female, at least 18 years of age.
. Histologically or cytologically confirmed diagnosis of breast or colon cancer.
. Radiologically documented measurable disease
. Planned to receive capecitabine at 1000-1250 mg/m2 PO twice daily and has experienced grade 1 or greater HFS on a previous cycle of capecitabine.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at study entry.
. Adequate liver function with SGOT and SGPT \< 2.5 times upper limits of normal.
. Adequate bone marrow function evidence by WBC \> 2500/mm3, PMN \>2000/mm3 and platelet count \> 100,000/mm3.
Exclusion criteria
. Known DPD deficiency
. Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.
. History of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for \>28 days.
. Stroke, major surgery, or other major tissue injury within 30 days before study entry.
. Myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ECG abnormalities.
. No concurrent or planned use of topical pharmaceuticals to the hands or feet other than Aquaphor®.
. No concurrent or planned use of cytotoxic drugs (other than capecitabine).
. No other dermatologic condition that may complicate evaluation of the study.