Squamous Cell Carcinoma of Head and NeckNCT05792228
A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting
A study testing nurse-led standardized intervention in people with Squamous Cell Carcinoma of Head and Neck and Chemotherapy Induced Nausea and Vomiting, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- nurse-led standardized intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2023to 12 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with head and neck squamous cell carcinoma
- receive first cycle of chemotherapy
- receive cisplatin-based chemotherapy
- able to read and write.
Who cannot join
- experience nausea or vomiting in 24 hours before receiving chemotherapy
- mental disturbance
- disturbance of consciousness
- history of stomach disease or surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin medical universtiy cancer institute and hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: 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.
Read the 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.
- Being tested
- nurse-led standardized intervention
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led standardized interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | 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. Receives: Other: nurse-led standardized intervention |
| The control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chemotherapy-induced nausea and vomiting
The number of patients who have chemotherapy-induced nausea and vomiting during the first cycle of chemotherapy will be collected.
Measured: Five days after administration of cisplatin
The degree of chemotherapy-induced nausea and vomiting
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
Measured: Five days after administration of cisplatin
The influence of chemotherapy-induced nausea and vomiting on patients' quality of life
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
Measured: Five days after administration of cisplatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start2 Apr 2023
- Primary completion2 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792228
- Sponsor's protocol ID
- ZC20009
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao J, Chen C, Wang Y, Liu M, Han X, Li H. A nurse-led multidomain intervention to improve the management of chemotherapy-induced nausea and vomiting in patients with head and neck cancers: A randomized controlled trial. Eur J Oncol Nurs. 2024 Jun;70:102615. doi: 10.1016/j.ejon.2024.102615. Epub 2024 May 20.
PubMed 38797114
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting in Patients With Head and Neck Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT05792228
- Acronym / sponsor ID
- ZC20009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Other: nurse-led standardized interventionThe 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. |
| The control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with head and neck squamous cell carcinoma
- receive first cycle of chemotherapy
- receive cisplatin-based chemotherapy
- able to read and write.
Key exclusion criteria (4 listed)
- experience nausea or vomiting in 24 hours before receiving chemotherapy
- mental disturbance
- disturbance of consciousness
- history of stomach disease or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-led standardized interventionOnce 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. | Other | The intervention group |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 38797114Cao J, Chen C, Wang Y, Liu M, Han X, Li H. A nurse-led multidomain intervention to improve the management of chemotherapy-induced nausea and vomiting in patients with head and neck cancers: A randomized controlled trial. Eur J Oncol Nurs. 2024 Jun;70:102615. doi: 10.1016/j.ejon.2024.102615. Epub 2024 May 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led standardized intervention in people with Squamous Cell Carcinoma of Head and Neck and Chemotherapy Induced Nausea and Vomiting, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chemotherapy-induced nausea and vomiting (time frame: Five days after administration of cisplatin). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.