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Zinc Supplements in Lowering Cadmium Levels in Smokers

Primary Purpose

Bladder Cancer, Cervical Cancer, Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
zinc oxide
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Reduction of cadmium levels
Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits
Correlation of increased cadmium levels with decreased mismatch repair
Reversal of cadmium-induced inhibition of mismatch repair

Secondary Outcome Measures

Full Information

First Posted
September 13, 2006
Last Updated
May 25, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00376987
Brief Title
Zinc Supplements in Lowering Cadmium Levels in Smokers
Official Title
Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
zinc oxide
Intervention Description
Oral daily dietary supplement containing 80 mg Zinc oxide
Primary Outcome Measure Information:
Title
Reduction of cadmium levels
Time Frame
17 weeks
Title
Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits
Time Frame
17 weeks
Title
Correlation of increased cadmium levels with decreased mismatch repair
Time Frame
17 weeks
Title
Reversal of cadmium-induced inhibition of mismatch repair
Time Frame
17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary G. Schwartz, MD, PhD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

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