DRIHNC - Dehydration Reduction in Head & Neck Cancer
Dehydration, Head & Neck Cancer, Esophageal Cancer
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
Active Comparator
Experimental
Control - Standard of Care
Experimental - Gatorade
Standard of care nutritional support
Standard of care nutritional support with the addition of daily Gatorade G2