DRIHNC - Dehydration Reduction in Head & Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03799380|
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : November 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dehydration Head & Neck Cancer Esophageal Cancer||Dietary Supplement: Gatorade G2 Dietary Supplement: Standard of care nutritional support||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||DRIHNC - Dehydration Reduction in Head & Neck Cancer: Daily Oral Fluid and Electrolyte Maintenance to Prevent Acute Care Clinic and Emergency Department Visits for Patients Receiving Radiation With or Without Chemotherapy/Immunotherapy for Head & Neck and Esophageal Cancer.|
|Actual Study Start Date :||November 5, 2019|
|Actual Primary Completion Date :||May 5, 2021|
|Actual Study Completion Date :||May 5, 2021|
Active Comparator: Control - Standard of Care
Standard of care nutritional support
Dietary Supplement: Standard of care nutritional support
Standard of care nutritional support
Experimental: Experimental - Gatorade
Standard of care nutritional support with the addition of daily Gatorade G2
Dietary Supplement: Gatorade G2
Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)
- ACC visits [ Time Frame: Up to 11 weeks after start of treatment ]ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
- ED visits [ Time Frame: Up to 11 weeks after start of treatment ]Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
- Incidence of orthostatic vital signs [ Time Frame: Up to 11 weeks after start of treatment ]Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.
- Missed days of radiation +/- chemotherapy/immunotherapy treatment [ Time Frame: Up to 7 weeks after start of treatment ]Number of missed days of radiation treatment among H&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799380
|United States, Ohio|
|Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Elisha Fredman, MD||University Hospitals Cleveland Medical Center|