Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

Not Applicable

Completed

• Conditions: Liver and Intrahepatic Bile Duct Carcinoma; Unresectable Pancreatic Carcinoma; Gastric Carcinoma; Unresectable Esophageal Carcinoma
• Interventions: Dietary Supplement: Zinc

• Registration Number: NCT03819088
• Lead Sponsor: Emory University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-04-17
• Primary Completion: 2021-10-05
• Study Completion: 2021-10-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (zinc months 1 and 2)	Zinc	Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
Group II (zinc months 3 and 4)	Zinc	Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.

Primary Outcome Measures

Name	Time	Method
Quality of life scores	Up to 4 months after study start	Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.

Secondary Outcome Measures

Name	Time	Method
Serum albumin level	Up to 4 months after study start	Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.
Serum zinc level	Up to 4 months after study start	Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.

Trial Locations

Locations (2)

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States