NCT07784855Not yet recruiting
Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 21 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- West Virginia University
- Diseases
- Head and neck cancer
- NCT number
- NCT07784855
What you commit to
- Study type: Interventional
- Planned participants: 180
- From Oct 2026 to the primary completion date, Apr 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Dependency on enteral nutrition and hydration prior to enrollment.
Other illness
- History of congestive heart failure.
Other
- Nasopharyngeal squamous cell carcinomas, nasal cavity and paranasal sinus squamous cell carcinomas.
- Use of diuretics that cannot be safely held during study treatment (participants who are able to temporarily discontinue diuretics during treatment are eligible).
Who the study is looking for
- ECOG 0-2
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| WVU Medicine United Hospital Center Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| WVU Medicine Berkeley Medical Center Coordinator of this site? Confirm its status | Martinsburg | United States | Unknown status |
| West Virginia University Cancer Institute Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| WVU Medicine Camden Clark Medical Center Coordinator of this site? Confirm its status | Parkersburg | United States | Unknown status |
| WVU Medicine Princeton Community Hospital Coordinator of this site? Confirm its status | Princeton | United States | Unknown status |
| WVU Medicine Wheeling Hospital Coordinator of this site? Confirm its status | Wheeling | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.