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Zinc Supplementation for Gastrointestinal Cancer
N/A
Waitlist Available
Led By Olatunji B. Alese, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months after study start
Awards & highlights
Study Summary
This trial looks at whether zinc can help improve quality of life for people with gastrointestinal cancer who can't have surgery, and are receiving chemotherapy. Zinc may help by preventing zinc deficiency.
Who is the study for?
This trial is for adults with newly diagnosed, inoperable gastrointestinal cancers (stomach, esophageal, pancreatic, or biliary) who are about to start chemotherapy. They must be able to give consent and plan to receive treatment at an Emory Cancer Center. Pregnant or breastfeeding women and those who have had previous cancer treatments are excluded.Check my eligibility
What is being tested?
The study is testing whether zinc supplements can improve the quality of life for patients undergoing chemotherapy for certain gastrointestinal cancers. It's a randomized trial which means participants will be randomly assigned to either receive zinc or not.See study design
What are the potential side effects?
Zinc supplementation may cause minor side effects such as nausea, vomiting, diarrhea, metallic taste in mouth, kidney and stomach damage if taken in high doses over long periods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months after study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months after study start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of life scores
Secondary outcome measures
Serum albumin level
Serum zinc level
Side effects data
From 2008 Phase 4 trial • 1000 Patients • NCT004701584%
infectious hospitalizations
1%
noninfectious hospitalizations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Separate Iron and Zinc
Placebo
Combined Iron and Zinc
Iron Alone
Zinc Alone
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (zinc months 3 and 4)Experimental Treatment1 Intervention
Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.
Group II: Group I (zinc months 1 and 2)Experimental Treatment1 Intervention
Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinc
2005
Completed Phase 4
~17050
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,556 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,650 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,562 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with non-operable stomach, stomach and esophagus, pancreas, or bile duct cancer.You are planning to receive chemotherapy at an Emory Cancer Center.You have not received chemotherapy or radiation therapy for newly diagnosed stomach, stomach and esophagus, pancreas, or bile duct cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (zinc months 3 and 4)
- Group 2: Group I (zinc months 1 and 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration for this research endeavor still accepting participants?
"According to clinicaltrials.gov, this medical trial is not presently looking for patients. After being posted on April 17th 2019 and lastly modified on April 1st 2022, there are 3590 other studies that are actively recruiting individuals at the moment."
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