Clinical Trial: NCT03799380 - My Cancer Genome

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:

Suspended

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03799380

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

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

Name	Type	Description	Interventions
Control - Standard of Care	Active Comparator	Standard of care nutritional support
Experimental - Gatorade	Experimental	Standard 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

December 11, 2020

Clinical Trials /

DRIHNC - Dehydration Reduction in Head & Neck Cancer