Status:
COMPLETED
DRIHNC - Dehydration Reduction in Head & Neck Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Dehydration
Head & Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ar...
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 admiss...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03799380
Start Date
November 5 2019
End Date
May 5 2021
Last Update
November 3 2021
Active Locations (1)
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1
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106