Bladder Cancer Clinical Trial
Zinc Supplements in Lowering Cadmium Levels in Smokers
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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.