<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03799380</url>
  </required_header>
  <id_info>
    <org_study_id>CASE8318</org_study_id>
    <nct_id>NCT03799380</nct_id>
  </id_info>
  <brief_title>DRIHNC - Dehydration Reduction in Head &amp; Neck Cancer</brief_title>
  <official_title>DRIHNC - Dehydration Reduction in Head &amp; 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 &amp; Neck and Esophageal Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to decrease the rate of visits to the Emergency Department (ED)&#xD;
      and Acute Care Clinics (ACC) for dehydration for head &amp; neck (H&amp;N) and esophageal cancer&#xD;
      patients that are given Gatorade while receiving radiation therapy with or without&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among patients with cancer of the H&amp;N or esophagus, complications related to dehydration are&#xD;
      fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even&#xD;
      inpatient admission. By instructing participants to drink a reasonable amount of a common&#xD;
      electrolyte-rich energy drink from the initiation of treatment through its completion, the&#xD;
      hypothesis will be tested that this inexpensive and easily administered preventative strategy&#xD;
      can significantly decrease the rate of ACC and ED visits.&#xD;
&#xD;
      The objectives of this study are to decrease the frequency of ACC visits during the course of&#xD;
      radiation therapy and decrease the frequency of ED visits during the course of radiation&#xD;
      therapy. The study team also seeks to decrease the incidence of orthostatic vital signs&#xD;
      during the course of radiation therapy and decrease the number of days of missed treatments&#xD;
      due to radiation toxicity during the course of radiation therapy.&#xD;
&#xD;
      In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course&#xD;
      of radiation, along with standard of care nutritional support from dietitians. The randomized&#xD;
      Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional&#xD;
      support. Group 2 will receive standard of care nutritional support plus the study agent,&#xD;
      Gatorade G2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2019</start_date>
  <completion_date type="Actual">May 5, 2021</completion_date>
  <primary_completion_date type="Actual">May 5, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACC visits</measure>
    <time_frame>Up to 11 weeks after start of treatment</time_frame>
    <description>ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ED visits</measure>
    <time_frame>Up to 11 weeks after start of treatment</time_frame>
    <description>Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of orthostatic vital signs</measure>
    <time_frame>Up to 11 weeks after start of treatment</time_frame>
    <description>Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missed days of radiation +/- chemotherapy/immunotherapy treatment</measure>
    <time_frame>Up to 7 weeks after start of treatment</time_frame>
    <description>Number of missed days of radiation treatment among H&amp;N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Dehydration</condition>
  <condition>Head &amp; Neck Cancer</condition>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Control - Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care nutritional support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental - Gatorade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard of care nutritional support with the addition of daily Gatorade G2</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Gatorade G2</intervention_name>
    <description>Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)</description>
    <arm_group_label>Experimental - Gatorade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Standard of care nutritional support</intervention_name>
    <description>Standard of care nutritional support</description>
    <arm_group_label>Control - Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Subjects must have histologically confirmed primary invasive cancer of the H&amp;N&#xD;
        (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus.&#xD;
&#xD;
        Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal&#xD;
        undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either&#xD;
        definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO)&#xD;
&#xD;
          -  Subjects must have received no prior radiation therapy to the head, neck, thorax or&#xD;
             abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell&#xD;
             carcinoma.&#xD;
&#xD;
          -  ECOG Performance status 0-2.&#xD;
&#xD;
          -  Life expectancy of ≥ 3 months, in the opinion of and as documented by the&#xD;
             investigator.&#xD;
&#xD;
          -  Subjects must have organ and marrow function based on lab values deemed acceptable to&#xD;
             proceed with radiation therapy. No additional or specific lab value cutoffs are&#xD;
             required for this protocol given the nature of the intervention. General guidelines&#xD;
             are provided below.&#xD;
&#xD;
          -  Hemoglobin ≥ 7 g/dl&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 500/mcL&#xD;
&#xD;
          -  Platelet count ≥ 50,000/mcL&#xD;
&#xD;
          -  Total bilirubin within normal institutional limits&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document.&#xD;
&#xD;
          -  HIV-positive subjects on combination antiretroviral therapy are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The presence of any of the following will exclude a subject from study enrollment.&#xD;
&#xD;
          -  Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with&#xD;
             the exception of scalp squamous cell or basal cell carcinoma.&#xD;
&#xD;
          -  Patients with active, uncontrolled, symptomatic volume overload congestive heart&#xD;
             failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisha Fredman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>November 2, 2021</last_update_submitted>
  <last_update_submitted_qc>November 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799380
org study id: CASE8318
nct id: NCT03799380
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: ACC visits
time frame: Up to 11 weeks after start of treatment
description: ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
measure: ED visits
time frame: Up to 11 weeks after start of treatment
description: Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
measure: Incidence of orthostatic vital signs
time frame: Up to 11 weeks after start of treatment
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
description: Number of missed days of radiation treatment among H&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.
arm group label: Control - Standard of Care
arm group type: Active Comparator
description: Standard of care nutritional support
arm group label: Experimental - Gatorade
arm group type: Experimental
description: Standard of care nutritional support with the addition of daily Gatorade G2
intervention type: Dietary Supplement
intervention name: Gatorade G2
description: Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)
arm group label: Experimental - Gatorade
intervention type: Dietary Supplement
intervention name: Standard of care nutritional support
description: Standard of care nutritional support
arm group label: Control - Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elisha Fredman, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Dehydration