DRIHNC - Dehydration Reduction in Head & Neck Cancer

NCT03799380 | Completed DMC

• 1 other identifier: CASE8318
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration; Head & Neck Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

• ACC visits

  ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

  Up to 11 weeks after start of treatment

• ED visits

  Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

  Up to 11 weeks after start of treatment

Secondary Outcomes (2)

• Incidence of orthostatic vital signs

  Up to 11 weeks after start of treatment

• Missed days of radiation +/- chemotherapy/immunotherapy treatment

  Up to 7 weeks after start of treatment

Study Arms (2)

Control - Standard of Care

ACTIVE COMPARATOR

Standard of care nutritional support

Dietary Supplement: Standard of care nutritional support

Experimental - Gatorade

EXPERIMENTAL

Standard of care nutritional support with the addition of daily Gatorade G2

Dietary Supplement: Gatorade G2

Interventions

Gatorade G2 DIETARY_SUPPLEMENT

Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)

Experimental - Gatorade

Standard of care nutritional support DIETARY_SUPPLEMENT

Standard of care nutritional support

Control - Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Dehydration; Head and Neck Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Elisha Fredman, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: November 5, 2019
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

US (1)