Back to resultsDRIHNC - Dehydration Reduction in Head & Neck Cancer
Primary Purpose
Dehydration, Head & Neck Cancer, Esophageal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gatorade G2
Standard of care nutritional support
Sponsored by
About this trial
This is an interventional supportive care trial for Dehydration
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.
Sites / Locations
- Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control - Standard of Care
Experimental - Gatorade
Arm Description
Standard of care nutritional support
Standard of care nutritional support with the addition of daily Gatorade G2
Outcomes
Primary Outcome Measures
ACC visits
ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
ED visits
Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Secondary Outcome Measures
Incidence of orthostatic vital signs
Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.
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.
Full Information
NCT ID
NCT03799380
First Posted
January 8, 2019
Last Updated
November 2, 2021
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03799380
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
May 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Head & Neck Cancer, Esophageal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care nutritional support
Arm Title
Experimental - Gatorade
Arm Type
Experimental
Arm Description
Standard of care nutritional support with the addition of daily Gatorade G2
Intervention Type
Dietary Supplement
Intervention Name(s)
Gatorade G2
Intervention Description
Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard of care nutritional support
Intervention Description
Standard of care nutritional support
Primary Outcome Measure Information:
Title
ACC visits
Description
ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Time Frame
Up to 11 weeks after start of treatment
Title
ED visits
Description
Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Time Frame
Up to 11 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Incidence of orthostatic vital signs
Description
Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.
Time Frame
Up to 11 weeks after start of treatment
Title
Missed days of radiation +/- chemotherapy/immunotherapy 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.
Time Frame
Up to 7 weeks after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisha Fredman, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
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DRIHNC - Dehydration Reduction in Head & Neck Cancer
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