A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting

November 12, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin medical universtiy cancer institute and hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention group
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.
Other: nurse-led standardized intervention
Once the patient in the intervention group decided to undergo cisplatin-based chemotherapy, the nurses would assess the risk factors associated with chemotherapy-induced nausea and vomiting (CINV) and reported to the physicians. During the chemotherapy, nurses would provide education on prevention and control of CINV using web-based approaches. All patients received standard antiemetic regimen, which included Aprepitant, 5-Hydroxytryptamine3-receptor antagonists, and Dexamethasone. If the physician's prescription was not accordance with the standard antiemetic regimen, nurse would remind the physician to adjust the prescription. Patients were recommended to eat small and frequent meals slowly. Overly spicy, fatty, and sweet foods should be avoided. Music relaxation therapy was performed for 60 min each time, once a day, and 3 times in the whole chemotherapy cycle. Follow-up was delivered until the 5th day after chemotherapy.
No Intervention: The control group
The control group will receive the routine CINV management. Patients are given drugs to prevent and control emesis according to the physicians' individual prescriptions. Nurses provide related 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of chemotherapy-induced nausea and vomiting
Time Frame: 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.
Five days after administration of cisplatin
The degree of chemotherapy-induced nausea and vomiting
Time Frame: 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
Five days after administration of cisplatin
The influence of chemotherapy-induced nausea and vomiting on patients' quality of life
Time Frame: 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
Five days after administration of cisplatin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

October 12, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZC20009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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