This trial is active, not recruiting.

Conditions bladder cancer, cervical cancer, esophageal cancer, gastric cancer, head and neck cancer, kidney cancer, leukemia, liver cancer, lung cancer, pancreatic cancer, tobacco use disorder
Treatment zinc oxide
Phase phase 2
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date December 2003
End date October 2006
Trial size 61 participants
Trial identifier NCT00376987, CCCWFU-98903, CCCWFU-BG03-538, CDR0000495325


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose prevention

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?
Principal investigator Gary G. Schwartz, MD, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.