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Zinc Sulfate in Improving Quality of Life in Patients with Gastrointestinal Cancer That Cannot Be Removed by Surgery Who Are Receiving Chemotherapy

Status
Active
Cancer Type
Esophogeal Cancer
Liver Cancer / Hepatoblastoma
Pancreatic Cancer
Stomach/ Gastric Cancer
Trial Phase
Phase II
Eligibility
0 Years and older, Male and Female
Study Type
Supportive care
NCT 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 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.

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

Eligibility

  1. Patients who present to adult medical oncology outpatient clinic with new diagnosis and not resected gastric, gastro-esophageal, pancreatic or biliary cancer
  2. Patients plan to receive chemotherapy or chemo/radiation treatment for a minimum of 4 months at an Emory Cancer Center
  3. No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
  4. Patients must sign informed consent

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.