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

January 12, 2024 updated by: Olatunji Alese, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (zinc months 1 and 2)
Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
Dietary supplement: Zinc
Given PO
Other Names:
  • Zinc sulfate
Experimental: Group II (zinc months 3 and 4)
Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.
Dietary supplement: Zinc
Given PO
Other Names:
  • Zinc sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 months after study start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 months after study start
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.
Up to 4 months after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

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

Investigators

  • Principal Investigator: Olatunji B. Alese, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Actual)

October 5, 2021

Study Completion (Actual)

October 5, 2021

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00099791
  • P30CA138292 (U.S. NIH Grant/Contract)
  • NCI-2017-02467 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • Winship4173-17 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan may be reevaluated at the time of publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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