Squamous Cell Carcinoma of HypopharynxNCT07784855
Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
A study testing Scheduled IV Hydration and Clinician Assessment-Based IV Hydration in people with Squamous Cell Carcinoma of Hypopharynx and Squamous Cell Carcinoma of Larynx, run by West Virginia University at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of Oropharynx
- What is being tested?
- Scheduled IV Hydration and Clinician Assessment-Based IV Hydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
WVU Medicine United Hospital Center
Bridgeport, West Virginia, 26330
Sabrina Rexroad, 681-342-1000, sabrina.rexroad1@wvumedicine.org
WVU Medicine Berkeley Medical Center
Martinsburg, West Virginia, 25401
Valli White, 304-264-1220, valli.white@wvumedicine.org
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
Nina Moore, 304-293-2991, nina.moore@hsc.wvu.edu
Ella Betler, 304-293-4273, eibetler@hsc.wvu.edu
WVU Medicine Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Layla Tannaoury, 304-424-2585, Layla.tannoury@wvumedicine.org,
WVU Medicine Princeton Community Hospital
Princeton, West Virginia, 24740
Melissa Boggess, 304-487-7515, melissa.boggess1@wvumedicine.org
WVU Medicine Wheeling Hospital
Wheeling, West Virginia, 26003
Maher Kali, 304-243-7045, maher.kali@wvumedicine.org
About this study
Official title: WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
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.
- Conditions
- Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Oral Cavity
- Being tested
- Scheduled IV Hydration, Clinician Assessment-Based IV Hydration
- Keywords
- Treatment related toxicities, IV hydration
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled IV HydrationOther
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.
Clinician Assessment-Based IV HydrationOther
IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled IV Hydration | Experimental | Participants will receive scheduled IV hydration approximately twice per week throughout the treatment period. IV fluids will continue even if chemoradiotherapy infusion is held due to toxicities or cytopenias. Receives: Other: Scheduled IV Hydration |
| Clinician Assessment-Based IV Hydration | Other | Participants will receive IV fluids (normal saline) only as clinically indicated and ordered by their treating clinician, per standard of care. IV fluids may continue if chemoradiotherapy infusion is held due to toxicities or cytopenias, at the discretion of the treating clinician. Receives: Other: Clinician Assessment-Based IV Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest
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.
Measured: From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks)
Secondary outcomes (7)
Incidences of Individual Treatment-Related Toxicities of Interest
Incidence of treatment-related mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus of any grade, as assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Measured: From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks)
Incidence of Enteric Tube Placement
Incidence of participants requiring enteric feeding tube placement during treatment and follow-up.
Measured: From initiation of treatment through 6 months after completion of chemoradiotherapy
Incidence of Hematologic Toxicities
Incidence of leukopenia, anemia, and thrombocytopenia assessed during weeks 3-6 of concurrent chemoradiotherapy treatment as assessed according to NCI CTCAE v6.0.
Measured: Weeks 3-6 of concurrent chemoradiotherapy
Residual Grade of Toxicities of Interest at 3 Months
Residual severity (NCI CTCAE v6.0 Grades 0-5) of mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.
Measured: 3 months after completion of chemoradiotherapy
Residual grade of Toxicities of Interest at 6 Months
Residual severity (NCI CTCAE v6.0 Grades 0-5) of mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.
Measured: 6 months after completion of chemoradiotherapy
Complete Recovery of Toxicities of Interest at 3 Months
Incidence of participants with complete recovery (NCI CTCAE v6.0 Grade 0) from mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.
Measured: 3 months after completion of chemoradiotherapy
Complete Recovery of Toxicities of Interest at 6 Months
Incidence of participants with complete recovery (NCI CTCAE v6.0 Grade 0) from mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.
Measured: 6 months after completion of chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of HypopharynxStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Clump, West Virginia University
- Investigators
- Sidra Najeeb, MD, Principal investigator, WVU Cancer CenterDavid Clump, MD, PhD, Principal investigator, WVU Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784855
- Sponsor's protocol ID
- STUDY00000501
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study, including demographic information, eligibility criteria, treatment/exposure data, outcome assessments, and relevant follow-up data, will be made available to qualified researchers. Data that could directly identify participants will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07784855
- Acronym / sponsor ID
- STUDY00000501
- Conditions
- Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Oral Cavity
- Keywords
- Treatment related toxicities, IV hydration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled IV Hydration | Experimental | Other: Scheduled IV HydrationParticipants will receive scheduled IV hydration approximately twice per week throughout the treatment period. IV fluids will continue even if chemoradiotherapy infusion is held due to toxicities or cytopenias. |
| Clinician Assessment-Based IV Hydration | Other | Other: Clinician Assessment-Based IV HydrationParticipants will receive IV fluids (normal saline) only as clinically indicated and ordered by their treating clinician, per standard of care. IV fluids may continue if chemoradiotherapy infusion is held due to toxicities or cytopenias, at the discretion of the treating clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled IV HydrationNormal 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 | Scheduled IV Hydration |
| Clinician Assessment-Based IV HydrationIV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care. | Other | Clinician Assessment-Based IV Hydration |
Primary outcome
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.
7 secondary outcomes
Incidences of Individual Treatment-Related Toxicities of Interest
Time frame: From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks)
Incidence of Enteric Tube Placement
Time frame: From initiation of treatment through 6 months after completion of chemoradiotherapy
Incidence of Hematologic Toxicities
Time frame: Weeks 3-6 of concurrent chemoradiotherapy
Residual Grade of Toxicities of Interest at 3 Months
Time frame: 3 months after completion of chemoradiotherapy
Residual grade of Toxicities of Interest at 6 Months
Time frame: 6 months after completion of chemoradiotherapy
Complete Recovery of Toxicities of Interest at 3 Months
Time frame: 3 months after completion of chemoradiotherapy
Complete Recovery of Toxicities of Interest at 6 Months
Time frame: 6 months after completion of chemoradiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study, including demographic information, eligibility criteria, treatment/exposure data, outcome assessments, and relevant follow-up data, will be made available to qualified researchers. Data that could directly identify participants will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sidra Najeeb, MD principal investigator
WVU Cancer Center
David Clump, MD, PhD principal investigator
WVU Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled IV Hydration and Clinician Assessment-Based IV Hydration in people with Squamous Cell Carcinoma of Hypopharynx and Squamous Cell Carcinoma of Larynx, run by West Virginia University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Moore (304-293-2991, nina.moore@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.