Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
alpha-Tocopherol
Isotretinoin
Tocopherols
Tocotrienols
Tretinoin
Vitamin E
Vitamins
Criteria
DISEASE CHARACTERISTICS: Current smokers with 20+ packs per year history of smoking OR
Former smokers who discontinued smoking 1 year prior to registration (less than 5
cigarettes in the prior year) and had a 20+ packs per year history prior to discontinuing
smoking

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater
than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 40 IU/mL OR SGPT
less than IU/mL Renal: Not specified Other: Fasting triglycerides less than 320 mg/dL No
prior malignancy in the past 5 years except nonmelanoma skin cancer or noninvasive cervical
cancer No history of malabsorption syndrome Not pregnant Effective contraception required
of all fertile persons

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
isotretinoin Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified Other: No prior warfarin or its derivatives At least 3 months since megadose
vitamin A (greater than 25,000 IU/day) or beta-carotene greater than 30 mg/day or
alpha-tocopherol at least 400 IU daily No concurrent megadose vitamin A (greater than
25,000 IU/day), beta-carotene greater than 30 mg/day, alpha-tocopherol at least 400 IU
daily, or other daily supplements and tonics