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NCT Number: NCT03819088

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

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.

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Key information

Conditions

Gastric Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Liver Diseases Liver Neoplasms Liver and Intrahepatic Bile Duct Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms Unresectable Esophageal Carcinoma Unresectable Pancreatic Carcinoma

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

Dietary Supplement

Given PO

Other names: Zinc sulfate

Primary outcomes

  1. Quality of life scores

    Time frame: Up to 4 months after study start

    Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.

Secondary outcomes

  1. Serum zinc level

    Time frame: 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.

  2. Serum albumin level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 28, 2019
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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