Esophageal Cancer Clinical Trial

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

Summary

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.

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Full Description

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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Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

17

Study ID:

NCT03819088

Recruitment Status:

Active, not recruiting

Sponsor:

Emory University

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There are 2 Locations for this study

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Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta Georgia, 30342, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

17

Study ID:

NCT03819088

Recruitment Status:

Active, not recruiting

Sponsor:


Emory University

How clear is this clinincal trial information?

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