Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy

Conditions
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Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma, Unresectable Pancreatic Carcinoma

Intervention / Treatment
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* Dietary Supplement: Zinc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer Patients plan to receive chemotherapy at an Emory Cancer Center No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer Patients must sign informed consent Exclusion Criteria: Zinc supplementation is not indicated for pregnant or lactating women therefore, this is an exclusion criteria and women of childbearing age will complete a pregnancy test
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (zinc months 1 and 2)<br>Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy. | Dietary Supplement: Zinc<br>* Given PO<br>* Other names: Zinc sulfate;|
| Experimental: Group II (zinc months 3 and 4)<br>Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy. | Dietary Supplement: Zinc<br>* Given PO<br>* Other names: Zinc sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Up to 4 months after study start |