Gastric CarcinomaNCT03819088
Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
A study testing Zinc in people with Gastric Carcinoma and Liver and Intrahepatic Bile Duct Carcinoma, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma
- What is being tested?
- Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2019to 22 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma, Unresectable Pancreatic Carcinoma
- Being tested
- Zinc
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDietary supplement
Also called Zinc sulfate
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (zinc months 1 and 2) | Experimental | Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy. Receives: Dietary Supplement: Zinc |
| Group II (zinc months 3 and 4) | Experimental | Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy. Receives: Dietary Supplement: Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life scores
Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.
Measured: Up to 4 months after study start
Secondary outcomes (2)
Serum zinc level
Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.
Measured: Up to 4 months after study start
Serum albumin level
Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.
Measured: Up to 4 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start17 Apr 2019
- Primary completion5 Oct 2021
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Olatunji Alese, Emory University
- Investigators
- Olatunji B. Alese, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819088
- Sponsor's protocol ID
- IRB00099791
- Other IDs
- NCI-2017-02467, Winship4173-17, P30CA138292
- Status last verified
- Oct 2025
- First submitted
- 25 Jan 2019
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan may be reevaluated at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
- ClinicalTrials.gov ID
- NCT03819088
- Acronym / sponsor ID
- IRB00099791
- Conditions
- Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma, Unresectable Pancreatic Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (zinc months 1 and 2) | Experimental | Dietary Supplement: ZincPatients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy. |
| Group II (zinc months 3 and 4) | Experimental | Dietary Supplement: ZincPatients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincAlso: Zinc sulfateGiven PO | Dietary supplement | Group I (zinc months 1 and 2), Group II (zinc months 3 and 4) |
Primary outcome
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.
2 secondary outcomes
Serum zinc level
Time frame: Up to 4 months after study start
Serum albumin level
Time frame: Up to 4 months after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No. Plan may be reevaluated at the time of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olatunji B. Alese, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with Gastric Carcinoma and Liver and Intrahepatic Bile Duct Carcinoma, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life scores (time frame: Up to 4 months after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.