Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
4 other identifiers
interventional
17
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedStudy Start
First participant enrolled
April 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedOctober 9, 2025
October 1, 2025
2.5 years
January 25, 2019
October 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Serum zinc level
Up to 4 months after study start
Serum albumin level
Up to 4 months after study start
Study Arms (2)
Group I (zinc months 1 and 2)
EXPERIMENTALPatients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
Group II (zinc months 3 and 4)
EXPERIMENTALPatients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olatunji B. Alese, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 25, 2019
First Posted
January 28, 2019
Study Start
April 17, 2019
Primary Completion
October 5, 2021
Study Completion
March 22, 2022
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Plan may be reevaluated at the time of publication.