This phase II trial studies how well oral fluid and electrolyte maintenance works in reducing dehydration in patients with head and neck or esophageal cancer who are undergoing radiation therapy. Oral fluid and electrolyte maintenance using Gatorade, Gatorade G2 or Gatorade G0 may help to prevent acute care clinic and emergency department visits due to dehydration in patients with head and neck or esophageal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03799380.
PRIMARY OBJECTIVE:
I. The addition of daily consumption of Gatorade, Gatorade G2 or Gatorade G0 will decrease the risk of dehydration in patients with head and neck (H&N) and esophageal cancer during the course of radiation therapy, quantified by a decreased frequency of acute care clinic and emergency department visits.
SECONDARY OBJECTIVES:
I. The addition of daily consumption of Gatorade, Gatorade G2 or Gatorade G0 will decrease the incidence of orthostatic vital signs among patients with H&N and esophageal cancer during the course of radiation therapy by improving hydration.
II. The addition of daily consumption of Gatorade, Gatorade G2 or Gatorade G0 will decrease the number of days of missed treatments due to treatment-related dehydration among patients with H&N and esophageal cancer during the course of radiation therapy.
OUTLINE:
PILOT: Patients receive Gatorade, Gatorade G2 or Gatorade G0 orally (PO) once daily (QD) or via percutaneous endoscopic (PEG) tube QD and standard of care nutritional support for the duration of standard of care radiation therapy.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care nutritional support for the duration of standard of care radiation therapy.
ARM II: Patients receive Gatorade, Gatorade G2 or Gatorade G0 PO QD or via PEG tube QD and standard of care nutritional support for the duration of standard of care radiation therapy.
After completion of study, patients are followed up for 4 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorElisha Tzvi Fredman
