Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer

N/ANot Yet RecruitingNCT07784855

West Virginia University180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

180

Conditions

Squamous Cell Carcinoma of Hypopharynx Squamous Cell Carcinoma of Larynx Squamous Cell Carcinoma of Oropharynx

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (6)

WVU Medicine United Hospital Center

Bridgeport, West Virginia, United States

WVU Medicine Berkeley Medical Center

Martinsburg, West Virginia, United States

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

WVU Medicine Camden Clark Medical Center

Parkersburg, West Virginia, United States

WVU Medicine Princeton Community Hospital

Princeton, West Virginia, United States

WVU Medicine Wheeling Hospital

Wheeling, West Virginia, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.