NCT07784855 · West Virginia University
Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Scheduled IV Hydration
Normal saline (0.9% sodium chloride) 1L of saline will be administered at each hydration visit. Participants will receive IV fluids on a planned schedule of twice a week, starting in Week 3 of chemoradiation treatment and continuing for one week after treatment is completed.
OTHER
Clinician Assessment-Based IV Hydration
IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.
Primary outcome measures
Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest
Time frame: From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks)
Incidence of participants experiencing at least one Grade ≥3 according to National Cancer Institute Common Terminology Criteria for Adverse Events v6.0 (NCI CTCAE) treatment-related toxicity of interest, including mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, or trismus, during concurrent chemoradiotherapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Non-nasopharyngeal squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx primary
- Planned for concurrent chemoradiotherapy (CCRT) with standard-of-care cisplatin-based regimen (IV cisplatin 100mg/m2 once every three weeks for up to three doses or IV cisplatin 40mg/m2 weekly) with concurrent radiotherapy (treatment duration approximately 6-7 weeks, per institutional standards).
- The use of immunotherapy in combination with CCRT is permitted and does not affect eligibility or group assignment.
Exclusion criteria
- Nasopharyngeal squamous cell carcinomas, nasal cavity and paranasal sinus squamous cell carcinomas.
- History of congestive heart failure.
- Dependency on enteral nutrition and hydration prior to enrollment.
- Use of diuretics that cannot be safely held during study treatment (participants who are able to temporarily discontinue diuretics during treatment are eligible).
Where
- Bridgeport, West Virginia
- Martinsburg, West Virginia
- Morgantown, West Virginia
- Parkersburg, West Virginia
- Princeton, West Virginia
- Wheeling, West Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2026 · Source of record for eligibility and locations