CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial
Status:
Completed
Trial end date:
2016-07-30
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the
growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer
will be compared to the usual cost of treating skin cancer. Participants are being asked to
be a part of this study because the participants have been treated for two or more skin
cancers within the past five (5) years. At least one of these cancers occurred on the face or
ears. Having had two or more skins cancers in the past 5 years makes it likely that
participants will develop additional skin cancers in the future.
Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is
a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams,
or gels that contain sunscreens can help protect the skin from premature aging and damage
that may lead to skin cancer.
The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers
and spots that might become skin cancer. However, 5-FU skin cream has never been studied to
see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be
used in this study.
In this study, one half of the patients will use the 5-FU cream and the other half will use a
skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active
drug in it.
Approximately twelve VA medical centers will work together in this study. About one thousand
(1000) patients will be in this study. The study is sponsored by the U.S. Department of
Veterans Affairs Cooperative Studies Program.