Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

Phase 3

Withdrawn

• Conditions: Lung Cancer
• Interventions: Dietary Supplement: Vitamin E (AT); Drug: Isotretinoin

• Registration Number: NCT00003599
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-09-10
• Study First Posted: 2004-09-13
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Vitamin E (AT)	Alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I)
Arm II	Isotretinoin	Isotretinoin orally plus AT placebo orally daily (arm II).
Arm I	Isotretinoin	Alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I)

Primary Outcome Measures

Name	Time	Method
Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity	6 Months