Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT05792228
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting in Patients With Head and Neck Squamous Cell Carcinomas
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: