Scheduled IV Fluids for Throat Cancer

Not yet recruiting at 5 trial locations
NM
EB
Overseen ByElla Betler
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: West Virginia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients undergoing concurrent chemoradiotherapy (CCRT) for head and neck squamous cell carcinoma frequently experience treatment-related toxicities including mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus. Many of these toxicities may be exacerbated by dehydration and are commonly managed with clinician-directed intravenous (IV) hydration. This study will evaluate whether scheduled IV hydration reduces the incidence and severity of treatment-related toxicities compared with clinician assessment-based hydration. Participants will be randomized 1:1 to scheduled IV hydration or clinician assessment-based IV hydration beginning in Week 3 of concurrent chemoradiotherapy and continuing through one week following completion of chemoradiotherapy.

Who Is on the Research Team?

SN

Sidra Najeeb, MD

Principal Investigator

WVU Cancer Center

DC

David Clump, MD, PhD

Principal Investigator

WVU Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am scheduled to receive cisplatin chemotherapy and radiation at the same time.
I have squamous cell cancer in my mouth, throat, or voice box (not the nasopharynx).
I am able to care for myself and perform daily activities.
See 1 more

Exclusion Criteria

Dependency on enteral nutrition and hydration prior to enrollment
I have a history of congestive heart failure.
My cancer is a squamous cell carcinoma of the nasopharynx, nasal cavity, or sinuses.
See 1 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Scheduled IV HydrationExperimental Treatment1 Intervention
Group II: Clinician Assessment-Based IV HydrationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials
192
Recruited
64,700+