A Randomized Study of the Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity in a Preliminary Chemoprevention Trial in Former and Current Smokers
OBJECTIVES: I. Determine whether the addition of alpha-tocopherol (AT; vitamin E) to
isotretinoin decreases the incidence of Grade II and higher toxicity of isotretinoin when
administered to former and current smokers. II. Determine the compliance rate of
isotretinoin of smoker and former smokers with or without AT over a six month period. III.
Determine the feasibility of recruiting former and current smokers with or without AT over a
six month period. IV. Determine the effect of isotretinoin administration on serum retinol
and retinol-binding protein levels in these patients.
OUTLINE: This is randomized, placebo controlled study. Patients are stratified by smoking
status (current smoker vs former smoker) and age (less than 50 vs 50 and over). Patients are
randomized to be take alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I) or
isotretinoin orally plus AT placebo orally daily (arm II). Treatment in each arm continues
for 6 months. Patients are followed at 1, 3, 6, and 7 months from start of treatment.
PROJECTED ACCRUAL: There will be 300 patients (150 per arm) accrued into this study over an
estimated 9 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity
Rodger J. Winn, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board