An interventional study of Scheduled IV Hydration and Clinician Assessment-Based IV Hydration in Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx and Squamous Cell Carcinoma of Oropharynx, sponsored by West Virginia University. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by West Virginia University · Not applicable, Interventional, and Supportive care
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Among 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States — 217 open to participants now, 347 under way, 28 of them phase 3. Squamous Cell Carcinoma of Head and Neck · United States.
Among the 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States, this one is the 147th largest by planned enrollment of the 993 interventional ones that give a count, is one of 60 that started in 2026, is one of 71 with no phase, reaches primary completion later than 283 of the 346 other live ones, and was the 1,086th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →217 of the 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
University of Miami · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
Mayo Clinic · Sites in United States
Ages 18+
Aktis Oncology, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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1,099 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 519 · Phase 2 528 · Phase 3 83 · Phase 4 4
First in 1988; this study’s year is marked. 60 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 41 across the 993 interventional studies, 130 across the 63 observational. Of the 690 that completed or were terminated, 288 (42%) have results posted.
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420 of 1,099 have an industry lead sponsor. The 10 most frequent:
West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
West Virginia University has 3 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
107 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06998069Phase 3Brown UniversityHead and Neck Cancer Study Project in the Geriatric Population | 2026-12-01 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT04965792Dana-Farber Cancer InstitutePost-treatment Surveillance in HPV+ Oropharyngeal SCC | 2026-11 |
| NCT05600842University of California, IrvineDe-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx | 2026-11 |
| NCT02955290Roswell Park Cancer InstituteCIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer | 2026-11-25 |
Add all 107 to your calendar (.ics) → With an account.
Among the 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Scheduled IV Hydration
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.
Other: Clinician Assessment-Based 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.
IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.
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.
Time frame: From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after completion of chemoradiotherapy
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2029, 29 months later.
Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's planned 29 months is below that.
Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Squamous Cell Carcinoma of Head and Neck →