DRIHNC - Dehydration Reduction in Head & Neck Cancer

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.

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer; Dehydration; Head & Neck Cancer
• Intervention / Treatment: Dietary supplement: Standard of care nutritional support; Dietary supplement: Gatorade G2

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of orthostatic vital signs	Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.	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.	Up to 7 weeks after start of treatment

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Elisha Fredman, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2019
• Primary Completion (ACTUAL): May 5, 2021
• Study Completion (ACTUAL): May 5, 2021

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (ACTUAL): January 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Water-Electrolyte Imbalance; Head and Neck Neoplasms; Dehydration; Esophageal Neoplasms
• Other Study ID Numbers: CASE8318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No