Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
Conditions
Keywords
renal cell carcinoma, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, adult acute myeloid leukemia, pancreatic cancer, hypopharyngeal cancer, lip and oral cavity cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, non-small cell lung cancer, small cell lung cancer, adult primary liver cancer, tongue cancer, tobacco use disorder
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTzinc oxide
Oral daily dietary supplement containing 80 mg Zinc oxide
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Currently smoking ≥ 1 pack (20 cigarettes) per day * Baseline cadmium level ≥ 0.5 μg/L PATIENT CHARACTERISTICS: * Negative pregnancy test * Fertile patients must use effective contraception * No known gastrointestinal upset due to zinc vitamins or lozenges PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior and no other concurrent vitamins and zinc supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of cadmium levels | 17 weeks |
| Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits | 17 weeks |
| Correlation of increased cadmium levels with decreased mismatch repair | 17 weeks |
| Reversal of cadmium-induced inhibition of mismatch repair | 17 weeks |
Countries
United States
Outcome results
None listed