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临床试验/NCT05792228
NCT05792228已完成不适用

A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting in Patients With Head and Neck Squamous Cell Carcinomas

Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
The incidence of chemotherapy-induced nausea and vomiting

研究概览

简要总结

The goal of this clinical trial is to investigate the effect of a nurse-led standardized intervention on chemotherapy induced nausea and vomiting (CINV) in patients with head and neck squamous cell carcinoma. The main questions it aims to answer are: (1) what's the best practice to enhance the management of CINV; (2) how's the effect of the nurse-led standardized intervention on CINV in the patients treated with cisplatin-based chemotherapy. Participants in the intervention group will receive evidence-based, nurse-led standardized management of CINV, including nurse-led risk assessment, education on prevention and control of CINV, antiemetics following guidelines, dietary strategies, relaxation therapy, and follow up. Participants in the control group will receive routine care of CINV. The incidence and occurrence degree of CINV and its influence on patients' quality of life will be compared between the two groups.

详细描述

Chemotherapy with cisplatin is one of the most common treatments for patients with HNSCC, which could very possibly cause severe nausea and vomiting in last up to 5 days after administration of the drug. Nurses play an important role in managing CINV. The goal of this clinical trial is to investigate the effect of a nurse-led standardized intervention on chemotherapy induced nausea and vomiting (CINV) in patients with head and neck squamous cell carcinoma. The main questions it aims to answer are: (1) what's the best practice to enhance the management of CINV; (2) how's the effect of the nurse-led standardized intervention on CINV in the patients treated with cisplatin-based chemotherapy. Best practice to optimize CINV management for HNSCC patients who receive cisplatin-based chemotherapy have been instituted based on evidence. Participants in the intervention group will receive the evidence-based, nurse-led standardized management of CINV. Once the patient in the intervention group decide to undergo cisplatin-based chemotherapy, the nurses would assess the risk factors associated with chemotherapy-induced nausea and vomiting (CINV) and report to the physicians. During the chemotherapy, nurses will provide education on prevention and control of CINV using web-based approaches. All patients will receive standard antiemetic regimen, which includes Aprepitant, 5-HT3 RA, and Dexamethasone. If the physician's prescription are not accordance with the standard antiemetic regimen, nurse would remind the physician to adjust the prescription. Patients will be recommended to eat small and frequent meals slowly. Overly spicy, fatty, and sweet foods should be avoided. Music relaxation therapy will be performed for 60 min each time, once a day, and 3 times in the whole chemotherapy cycle. Follow-up will be delivered until the 5th day after chemotherapy. Guides on how to relieve nausea and vomiting will also be provided. Participants in the control group will receive routine care of CINV. Patients will be given drugs to prevent and control emesis according to the physicians' individual prescriptions. Nurses provide education about nausea and vomiting control and recommend patients to drink more water and eat light food. Patients will be given Metoclopramide when they are vomiting. The incidence and occurrence degree of CINV and its influence on patients' quality of life will be compared between the two groups.

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

入选标准

  • diagnosed with head and neck squamous cell carcinoma
  • receive first cycle of chemotherapy
  • receive cisplatin-based chemotherapy
  • able to read and write.

排除标准

  • experience nausea or vomiting in 24 hours before receiving chemotherapy
  • mental disturbance
  • disturbance of consciousness
  • history of stomach disease or surgery.

结局指标

主要结局

The incidence of chemotherapy-induced nausea and vomiting

时间窗: Five days after administration of cisplatin

The number of patients who have chemotherapy-induced nausea and vomiting during the first cycle of chemotherapy will be collected.

The degree of chemotherapy-induced nausea and vomiting

时间窗: Five days after administration of cisplatin

The degree of chemotherapy-induced nausea and vomiting would be assessed by the Common Terminology Criteria for Adverse Events v3.0 during the first cycle of chemotherapy

The influence of chemotherapy-induced nausea and vomiting on patients' quality of life

时间窗: Five days after administration of cisplatin

The influence of chemotherapy-induced nausea and vomiting on patients' quality of life would be assessed by the Functional Living Index-Emesis during the first cycle of chemotherapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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