Bladder CancerPhase 2NCT00376987
Zinc Supplements in Lowering Cadmium Levels in Smokers
A Phase 2 study testing zinc oxide in people with Bladder Cancer and Cervical Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 120 years
- Conditions the study is for
- Bladder Cancer, Cervical Cancer, Esophageal Cancer
- What is being tested?
- zinc oxide
- Type of treatment
- Pill or oral medicine
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?
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.
Read the 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.
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Being tested
- zinc oxide
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Leukemia, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc oxideDietary supplement
Oral daily dietary supplement containing 80 mg Zinc oxide
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of cadmium levels
Measured: 17 weeks
Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits
Measured: 17 weeks
Correlation of increased cadmium levels with decreased mismatch repair
Measured: 17 weeks
Reversal of cadmium-induced inhibition of mismatch repair
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startDec 2003
- Primary completionOct 2006
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary G. Schwartz, MD, PhD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376987
- Sponsor's protocol ID
- CDR0000495325
- Other IDs
- CCCWFU-98903, CCCWFU-BG03-538
- Status last verified
- Sep 2015
- First submitted
- 13 Sep 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?
- ClinicalTrials.gov ID
- NCT00376987
- Acronym / sponsor ID
- CDR0000495325
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Keywords
- renal cell carcinoma, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, adult acute myeloid leukemia, pancreatic cancer, hypopharyngeal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc oxideOral daily dietary supplement containing 80 mg Zinc oxide | Dietary supplement | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary G. Schwartz, MD, PhD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zinc oxide in people with Bladder Cancer and Cervical Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of cadmium levels (time frame: 17 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.