WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Scheduled IV Hydration
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.
干预措施: Scheduled IV Hydration (Other)
结局指标
主要结局
Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest
时间窗: 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.
次要结局
- Incidences of Individual Treatment-Related Toxicities of Interest(From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks))
- Incidence of Enteric Tube Placement(From initiation of treatment through 6 months after completion of chemoradiotherapy)
- Incidence of Hematologic Toxicities(Weeks 3-6 of concurrent chemoradiotherapy)
- Residual Grade of Toxicities of Interest at 3 Months(3 months after completion of chemoradiotherapy)
- Residual grade of Toxicities of Interest at 6 Months(6 months after completion of chemoradiotherapy)
- Complete Recovery of Toxicities of Interest at 3 Months(3 months after completion of chemoradiotherapy)
- Complete Recovery of Toxicities of Interest at 6 Months(6 months after completion of chemoradiotherapy)
研究者
David Clump
Professor and Chair Department of Radiology WVU Cancer Center
West Virginia University