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2019-04-17
2021-10-05
2021-10-05
17
NCT03819088
Emory University
Emory University
INTERVENTIONAL
Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-01-25 | N/A | 2024-01-12 |
2019-01-25 | N/A | 2024-01-17 |
2019-01-28 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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. | DIETARY_SUPPLEMENT: Zinc
|
| 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. | DIETARY_SUPPLEMENT: Zinc
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Serum zinc level | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
