Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Liver Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/30/2019 |
| Start Date: | January 1, 2020 |
| End Date: | January 31, 2022 |
| Contact: | Edith Brutcher, MSN |
| Email: | edith.brutcher@emoryhealthcare.org |
| Phone: | 404-778-2670 |
Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
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.
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.
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.
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.
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
- Exclusion from trial if zinc level is 1.5 x greater then upper limit of normal (ULN)
at baseline
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