RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.
OBJECTIVES: * Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms. * Arm I: Participants receive oral celecoxib twice daily for approximately 120 days. * Arm II: Participants receive oral placebo twice daily for approximately 120 days. Skin biopsies of UV-exposed sites are evaluated. Participants are followed for up to 5 weeks post-treatment. PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
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