RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage. PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.
OBJECTIVES: * Determine whether zinc supplements reduce cadmium levels in smokers. * Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits. * Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with VisiVite Smoker's Formula. * Determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair. * Determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair. OUTLINE: This is an open-label, nonrandomized study. Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity. Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis. After completion of study therapy, patients are followed for 5 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
61
Oral daily dietary supplement containing 80 mg Zinc oxide
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Reduction of cadmium levels
Time frame: 17 weeks
Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits
Time frame: 17 weeks
Correlation of increased cadmium levels with decreased mismatch repair
Time frame: 17 weeks
Reversal of cadmium-induced inhibition of mismatch repair
Time frame: 17 weeks
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