Zinc Supplements in Lowering Cadmium Levels in Smokers

Study Overview
=================
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.

Official Title
-----------------
Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?

Conditions
-----------------
Gastric Cancer, Cervical Cancer, Bladder Cancer, Esophageal Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: zinc oxide


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: zinc oxide|Oral daily dietary supplement containing 80 mg Zinc oxide|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco use disorder, 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