DRIHNC - Dehydration Reduction in Head & Neck Cancer

• ClinicalTrials.gov Identifier: NCT03799380
• Recruitment Status: Completed
• First Posted: January 10, 2019
• Last Update Posted: November 3, 2021
• Sponsor: Case Comprehensive Cancer Center
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

Brief Summary:

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.

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

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• 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

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Subjects must have histologically confirmed primary invasive cancer of the H&N (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus.

Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO)

• Subjects must have received no prior radiation therapy to the head, neck, thorax or abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell carcinoma.
• ECOG Performance status 0-2.
• Life expectancy of ≥ 3 months, in the opinion of and as documented by the investigator.
• Subjects must have organ and marrow function based on lab values deemed acceptable to proceed with radiation therapy. No additional or specific lab value cutoffs are required for this protocol given the nature of the intervention. General guidelines are provided below.
• Hemoglobin ≥ 7 g/dl
• Absolute neutrophil count ≥ 500/mcL
• Platelet count ≥ 50,000/mcL
• Total bilirubin within normal institutional limits
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• HIV-positive subjects on combination antiretroviral therapy are eligible.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment.

• Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with the exception of scalp squamous cell or basal cell carcinoma.
• Patients with active, uncontrolled, symptomatic volume overload congestive heart failure.

Contacts and Locations

Locations

United States, Ohio

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Elisha Fredman, MD; University Hospitals Cleveland Medical Center

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03799380
• Other Study ID Numbers: CASE8318
• First Posted: January 10, 2019
• Last Update Posted: November 3, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Head and Neck Neoplasms; Esophageal Neoplasms; Dehydration; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes