Zinc Sulfate in Improving Quality of Life in Patients with Gastrointestinal Cancer That Cannot Be Removed by Surgery Who Are Receiving Chemotherapy
Liver Cancer / Hepatoblastoma
Pancreatic Cancer
Stomach/ Gastric Cancer
0 Years and older, Male and Female
Winship4173-17 (primary)
NCI-2017-02467
IRB00099791
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 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 sulfate orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy. Patients also undergo collection of blood samples at screening and on study.
GROUP II: Patients receive zinc sulfate orally (PO) TID for months 3 and 4 only of the first 4 months on therapy. Patients also undergo collection of blood samples at screening and on study.
Eligibility
- Patients who present to adult medical oncology outpatient clinic with new diagnosis and not resected gastric, gastro-esophageal, pancreatic or biliary cancer
- Patients plan to receive chemotherapy or chemo/radiation treatment for a minimum of 4 months 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
Treatment Sites in Georgia
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