- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819088
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta, Georgia, United States, 30342
- Emory Saint Joseph's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
|
Given PO
Other Names:
|
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.
|
Given PO
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Olatunji B. Alese, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Pancreatic Diseases
- Stomach Neoplasms
- Carcinoma
- Pancreatic Neoplasms
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Dermatologic Agents
- Trace Elements
- Micronutrients
- Astringents
- Zinc
- Zinc Sulfate
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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