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NCT Number: NCT07784855

Scheduled IV 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.

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Key information

Conditions

Squamous Cell Carcinoma of Hypopharynx Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of Larynx Squamous Cell Carcinoma of Oral Cavity Squamous Cell Carcinoma of Oropharynx

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WVU Medicine United Hospital Center, Bridgeport, West Virginia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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).

Treatment and study plan

Scheduled IV Hydration

Other

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 Hydration

Other

IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. Incidence of Enteric Tube Placement

    Time frame: From initiation of treatment through 6 months after completion of chemoradiotherapy

    Incidence of participants requiring enteric feeding tube placement during treatment and follow-up.

  3. Incidence of Hematologic Toxicities

    Time frame: Weeks 3-6 of concurrent chemoradiotherapy

    Incidence of leukopenia, anemia, and thrombocytopenia assessed during weeks 3-6 of concurrent chemoradiotherapy treatment as assessed according to NCI CTCAE v6.0.

  4. Residual Grade of Toxicities of Interest at 3 Months

    Time frame: 3 months after completion of chemoradiotherapy

    Residual severity (NCI CTCAE v6.0 Grades 0-5) of mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.

  5. Residual grade of Toxicities of Interest at 6 Months

    Time frame: 6 months after completion of chemoradiotherapy

    Residual severity (NCI CTCAE v6.0 Grades 0-5) of mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.

  6. Complete Recovery of Toxicities of Interest at 3 Months

    Time frame: 3 months after completion of chemoradiotherapy

    Incidence of participants with complete recovery (NCI CTCAE v6.0 Grade 0) from mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.

  7. Complete Recovery of Toxicities of Interest at 6 Months

    Time frame: 6 months after completion of chemoradiotherapy

    Incidence of participants with complete recovery (NCI CTCAE v6.0 Grade 0) from mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.

Study contacts

Contact information is provided by the study sponsor or research team.

Ella Betler

CONTACT

[email protected]

304-293-4273

Nina Moore

CONTACT

[email protected]

304-293-2991

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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