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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03819088
Other study ID # IRB00099791
Secondary ID NCI-2017-02467Wi
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2019
Est. completion date October 5, 2021

Study information

Verified date January 2024
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 5, 2021
Est. primary completion date October 5, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Zinc
Given PO

Locations

Country Name City State
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia

Sponsors (3)

Lead Sponsor Collaborator
Emory University National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life scores Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey. Up to 4 months after study start
Secondary Serum zinc level Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg. Up to 4 months after study start
Secondary Serum albumin level Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl. Up to 4 months after study start
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