Active substances: Isotretinoin
Female patients of child-bearing age were required to comply with mandatory contraception and had to have had a negative pregnancy test within 2 weeks before enrollment.
Compliance was tested over an 8—12-week run-in period, during which time patients were asked to take three capsules of placebo per day.
Patients were then randomly assigned to one of the two study arms. The primary endpoint was the rate of second primary tumors, excluding basal and squamous cell skin carcinomas.
Secondary endpoints were the rates of smoking-associated cancers, which were defined as upper aerodigestive tract recurrences plus smoking-associated second primary tumors i.
Patients underwent annual chest X-rays; serial evaluations of lipid levels, complete blood counts, electrolytes, and liver function tests at baseline and at 6—12 months after randomization.
Serum cotinine levels, bleomycin fragility test results, and isotretinoin levels were determined at study enrollment or at random assignment and again at 6 and 12 months after the start of treatment on the randomized phase of the trial.
During years 2 and 3, patients were evaluated by study physicians at 4-month intervals for disease recurrence, second primary tumor development, and toxicity by use of complete blood counts, white blood cell differentials, electrolyte levels, liver function tests, fasting cholesterol and triglyceride levels, and an annual chest X-ray 14.
Treatment was suspended when patients developed grade II toxic effects 15 and resumed after resolution of toxic effects to grade I or less.
If grade II toxicity returned, then, upon resumption of treatment, patients were given two pills per day of either 10 mg isotretinoin or placebo. The dose was further reduced to one pill daily in patients with persistent grade II or higher toxicity.You should not breastfeed while using. Isotretinoin is not approved for use by anyone younger than 12 years.
Individuals with grade III toxic effects had their doses withheld until resolution of grade III or higher toxicity to grade 1 or lower toxicity and ultimately reduced to one pill daily, until all toxic effects returned to grade I levels or resolved.
Patients were then monitored for up to 4 additional years after completion of study drug for second primary tumor development, primary tumor recurrence, survival, and toxicity.
At all visits, patients underwent a physical examination and their disease status, both recurrence and development of a second primary tumor, as well as any toxicity to treatment was evaluated. There are 12 main meridians, and 8 secondary meridians.
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