Clinical Trials /

DRIHNC - Dehydration Reduction in Head & Neck Cancer

NCT03799380

Description:

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.

Related Conditions:
  • Head and Neck Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: DRIHNC - Dehydration Reduction in Head & Neck Cancer
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: CASE8318
  • NCT ID: NCT03799380

Conditions

  • Dehydration
  • Head & Neck Cancer
  • Esophageal Cancer

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Control - Standard of CareActive ComparatorStandard of care nutritional support
    Experimental - GatoradeExperimentalStandard of care nutritional support with the addition of daily Gatorade G2

      Eligibility 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.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:ACC visits
      Time Frame:Up to 11 weeks after start of treatment
      Safety Issue:
      Description:ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

      Secondary Outcome Measures

      Measure:Incidence of orthostatic vital signs
      Time Frame:Up to 11 weeks after start of treatment
      Safety Issue:
      Description:Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.
      Measure:Missed days of radiation +/- chemotherapy/immunotherapy treatment
      Time Frame:Up to 7 weeks after start of treatment
      Safety Issue:
      Description:Number of missed days of radiation treatment among H&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Case Comprehensive Cancer Center

      Last Updated

      October 1, 2020