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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 (NCT00003599)

National Cancer Institute (NCI)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy. PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer.
  • : Vitamin E (AT)
    Orally daily
    • alpha-tocopherol
    • AT
  • Drug: Isotretinoin
    Orally daily
    • Accutane
    • 13-cis-Retinoic acid
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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.
Status:
withdrawn
Type:
Interventional
Phase:
Start:
01 January, 0001
Updated:
16 February, 2012
Participants:
0
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