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


Phase 2
21 Years
N/A
Open (Enrolling)
Both
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

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Trial Information

Do Dietary Supplements of Zinc Reduce Serum 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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Reduction of cadmium levels

Outcome Time Frame:

17 weeks

Safety Issue:

No

Principal Investigator

Gary G. Schwartz, MD, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000495325

NCT ID:

NCT00376987

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • 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
  • tobacco use disorder
  • Urinary Bladder Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Leukemia
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Tobacco Use Disorder

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096