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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-98903 | |||
| CCCWFU-BG03-538 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc oxide | Dietary Supplement | Oral daily dietary supplement containing 80 mg Zinc oxide |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of cadmium levels | 17 weeks | |
| Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits | 17 weeks | |
| Correlation of increased cadmium levels with decreased mismatch repair | 17 weeks | |
| Reversal of cadmium-induced inhibition of mismatch repair | 17 weeks |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Gary G. Schwartz, MD, PhD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D014029 | Tobacco Use Disorder |
| D002292 | Carcinoma, Renal Cell |
| D015470 | Leukemia, Myeloid, Acute |
| D007012 | Hypopharyngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015034 | Zinc Oxide |
| ID | Term |
|---|---|
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |
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Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D006528 | Carcinoma, Hepatocellular |
| D014062 | Tongue Neoplasms |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007674 | Kidney Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007951 | Leukemia, Myeloid |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009059 | Mouth Diseases |
| D007818 | Laryngeal Diseases |
| D009302 | Nasopharyngeal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D014060 | Tongue Diseases |