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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-02467 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Winship4173-17 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.
PRIMARY OBJECTIVE:
I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.
SECONDARY OBJECTIVES:
I. Correlate hypoalbuminemia with serum zinc deficiency.
II. Correlate zinc deficiency with neutropenia.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.
GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (zinc months 1 and 2) | Experimental | Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy. |
|
| Group II (zinc months 3 and 4) | Experimental | Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Dietary Supplement | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life scores | Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey. | Up to 4 months after study start |
| Measure | Description | Time Frame |
|---|---|---|
| Serum zinc level | Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg. | Up to 4 months after study start |
| Serum albumin level | Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olatunji B. Alese, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| Emory Saint Joseph's Hospital |
Plan may be reevaluated at the time of publication.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2022 | Apr 28, 2023 |
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| Up to 4 months after study start |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D017967 | Zinc Compounds |
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