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Effects on QOL When Zinc is Supplemented in Patients with Upper GI Cancer on Chemotherapy

Status
Active
Cancer Type
Stomach/ Gastric Cancer
Trial Phase
Phase II
Eligibility
0 Years and older, Male and Female
Study Type
Supportive care
NCD ID
NCT03819088
Protocol IDs
Winship4173-17 (primary)
NCI-2017-02467
IRB00099791
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This randomized phase II studies how well zinc sulfate works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc sulfate may help to improve patient's quality of life by preventing zinc deficiency.

Objectives

PRIMARY OBJECTIVES:
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 sulfate orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.

GROUP II: Patients receive zinc sulfate orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.
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