Clinical trial · Interventional
DRIHNC - Dehydration Reduction in Head & Neck Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dehydration | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head & Neck Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gatorade G2 | Dietary Supplement | — | UNRESOLVED |
| Standard of care nutritional support | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control - Standard of Care
- description
- Standard of care nutritional support
- interventionNames
- Dietary Supplement: Standard of care nutritional support
- type
- EXPERIMENTAL
- label
- Experimental - Gatorade
- description
- Standard of care nutritional support with the addition of daily Gatorade G2
- interventionNames
- Dietary Supplement: Gatorade G2
Primary outcomes (2)
- measure
- ACC visits
- timeFrame
- Up to 11 weeks after start of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available