NCT03799380|CompletedDMC
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Sponsor study identifier
interventional
41
1 country
1
Study Start
November 5, 2019
Actual (reported)Primary Completion
May 5, 2021
Actual (reported)Study Completion
May 5, 2021
Actual (reported)The purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head \& neck (H\&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2019
Actual (reported)January 10, 2019
Actual (reported)November 5, 2019
Actual (reported)May 5, 2021
Actual (reported)May 5, 2021
Actual (reported)ACC visits
ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Up to 11 weeks after start of treatment
ED visits
Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Up to 11 weeks after start of treatment
Incidence of orthostatic vital signs
Up to 11 weeks after start of treatment
Missed days of radiation +/- chemotherapy/immunotherapy treatment
Up to 7 weeks after start of treatment
Standard of care nutritional support
Standard of care nutritional support with the addition of daily Gatorade G2
Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)
Standard of care nutritional support
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Elisha Fredman, MD
University Hospitals Cleveland Medical Center
41 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2019
First Posted
January 10, 2019
Study Start
November 5, 2019
Actual (reported)Using Urine Color as a Marker of Hydration Status
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 5, 2021
Actual (reported)Study Completion
May 5, 2021
Actual (reported)Last Updated
November 3, 2021
Record last verified: 2021-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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