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.
Among patients with cancer of the H\&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits. The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy. In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
41
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, United States
ACC visits
ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Time frame: 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.
Time frame: Up to 11 weeks after start of treatment
Incidence of orthostatic vital signs
Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.
Time frame: Up to 11 weeks after start of treatment
Missed days of radiation +/- chemotherapy/immunotherapy treatment
Number of missed days of radiation treatment among H\&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.
Time frame: Up to 7 weeks after start of treatment
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