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

Primary Purpose

Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zinc
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University Hospital/Winship Cancer Institute
  • Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (zinc months 1 and 2)

Group II (zinc months 3 and 4)

Arm Description

Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.

Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum zinc level
Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.
Serum albumin level
Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.

Full Information

First Posted
January 25, 2019
Last Updated
August 12, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03819088
Brief Title
Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
Official Title
Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
March 22, 2024 (Anticipated)
Study Completion Date
August 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma, Unresectable Pancreatic Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (zinc months 1 and 2)
Arm Type
Experimental
Arm Description
Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
Arm Title
Group II (zinc months 3 and 4)
Arm Type
Experimental
Arm Description
Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Other Intervention Name(s)
Zinc sulfate
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Quality of life scores
Description
Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.
Time Frame
Up to 4 months after study start
Secondary Outcome Measure Information:
Title
Serum zinc level
Description
Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.
Time Frame
Up to 4 months after study start
Title
Serum albumin level
Description
Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.
Time Frame
Up to 4 months after study start

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Jones, NP
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Plan may be reevaluated at the time of publication.

Learn more about this trial

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

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