Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of Oral Cavity, Squamous Cell Carcinoma of Oropharynx
Conditions
Keywords
Treatment related toxicities, IV hydration
Brief 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. 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.
Interventions
OTHERScheduled 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.
OTHERClinician Assessment-Based IV Hydration
IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidences of Individual Treatment-Related Toxicities of Interest | 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. |
| Incidence of Enteric Tube Placement | From initiation of treatment through 6 months after completion of chemoradiotherapy | Incidence of participants requiring enteric feeding tube placement during treatment and follow-up. |
| Incidence of Hematologic Toxicities | 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. |
| Residual Grade of Toxicities of Interest at 3 Months | 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. |
| Residual grade of Toxicities of Interest at 6 Months | 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. |
| Complete Recovery of Toxicities of Interest at 3 Months | 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. |
| Complete Recovery of Toxicities of Interest at 6 Months | 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. |
Countries
United States
Contacts
CONTACTNina Moore
CONTACTElla Betler
PRINCIPAL_INVESTIGATORSidra Najeeb, MD
WVU Cancer Center
PRINCIPAL_INVESTIGATORDavid Clump, MD, PhD
WVU Cancer Center
Outcome results
None listed