Head and Neck Squamous Cell Carcinoma (HNSCC)NCT06102447
Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma
A study testing Netopitam Palonosetron capsules and dexamethasone in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
The enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- Netopitam Palonosetron capsules and dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Jan 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75 years old;
- Head and neck tumors confirmed by histology or cytology (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer);
- Receive radical synchronous radiotherapy and chemotherapy;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score of the subjects was ≤ 2 points;
- Adequate organ and bone marrow function;
- The expected life is at least 12 weeks;
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- Pregnant or fertile patients (male or female) use reliable contraceptive measures;
- When screening female patients with potential pregnancy, the pregnancy test must be negative;
- The subjects voluntarily and strictly comply with the requirements of the research protocol and sign a written informed consent form.
Who cannot join
- Recurrent and metastatic head and neck tumors;
- Previously underwent tumor resection surgery for treatment;
- Patients with platinum drug intolerance;
- Receiving any known or potential antiemetic medication within 24 hours prior to the first day, or experiencing symptoms of vomiting, retching, or mild nausea within 24 hours prior to the first day;
- Take NK1（neurokinin-1） receptor antagonists or any study medication within 4 weeks before the start of the experiment;
- Use CYP3A4 inducer within 4 weeks before chemotherapy, and use CYP3A4 substrate or strong or moderate CYP3A4 inhibitor within 1 week;
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- Serious cardiovascular, pulmonary, diabetes, mental and other diseases;
- Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures;
- Drug and/or alcohol abuse;
- Hypocalcemia or any other condition that may cause vomiting;
- There are significant factors that affect the absorption of oral medication, such as chronic diarrhea and intestinal obstruction;
- The subject has allergic reactions to Netopitam Palonosetron capsules or any of their excipients;
- Within 30 days prior to the baseline visit, the subject participated in another clinical study and used any exploratory drugs or devices; Allow participation in observational research;
- The researcher determines other situations that may affect the progress of clinical research and the determination of research results.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
About this study
The enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. The aim of this study is to evaluate the antiemetic effect of Netopitam Palonosetron capsules and to explore the effectiveness of using Netopitam Palonosetron capsules again for antiemetic treatment during the study period when breakthrough vomiting occurs.
- Being tested
- Netopitam Palonosetron capsules and dexamethasone
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netopitam Palonosetron capsules and dexamethasoneDrug
On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: Netopitam Palonosetron capsules and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete response rate during synchronous radiotherapy and chemotherapy (defined as no vomiting episodes and no emergency medication).
Measured: 1 month
Secondary outcomes (7)
No significant nausea rate during synchronous radiotherapy and chemotherapy
Measured: 1 month
Nausea free rate during synchronous radiotherapy and chemotherapy
Measured: 1 month
No vomiting rate during synchronous radiotherapy and chemotherapy
Measured: 1 month
The rate of non emergency medication during synchronous radiotherapy and chemotherapy
Measured: 1 month
The prevalence and severity of oral/oropharyngeal mucositis during synchronous radiotherapy and chemotherapy
Measured: 1 month
Successful rescue rate of breakthrough vomiting: (defined as no vomiting within 48 hours)
Measured: 1 month
Evaluate the impact of medication on patients' daily activities of life (evaluated based on the nausea and vomiting questionnaire FLIE)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangkun Luo, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102447
- Sponsor's protocol ID
- SCCHEC-02-2023-076
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06102447
- Acronym / sponsor ID
- SCCHEC-02-2023-076
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Oct 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 enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. The aim of this study is to evaluate the antiemetic effect of Netopitam Palonosetron capsules and to explore the effectiveness of using Netopitam Palonosetron capsules again for antiemetic treatment during the study period when breakthrough vomiting occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Netopitam Palonosetron capsules and dexamethasone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, aged 18-75 years old;
- Head and neck tumors confirmed by histology or cytology (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer);
- Receive radical synchronous radiotherapy and chemotherapy;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score of the subjects was ≤ 2 points;
- Adequate organ and bone marrow function;
Key exclusion criteria (14 listed)
- Recurrent and metastatic head and neck tumors;
- Previously underwent tumor resection surgery for treatment;
- Patients with platinum drug intolerance;
- Receiving any known or potential antiemetic medication within 24 hours prior to the first day, or experiencing symptoms of vomiting, retching, or mild nausea within 24 hours prior to the first day;
- Take NK1（neurokinin-1） receptor antagonists or any study medication within 4 weeks before the start of the experiment;
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 |
|---|---|---|
| Netopitam Palonosetron capsules and dexamethasoneOn the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. | Drug | Treatment Group |
Primary outcome
The complete response rate during synchronous radiotherapy and chemotherapy (defined as no vomiting episodes and no emergency medication).
Time frame: 1 month
7 secondary outcomes
No significant nausea rate during synchronous radiotherapy and chemotherapy
Time frame: 1 month
Nausea free rate during synchronous radiotherapy and chemotherapy
Time frame: 1 month
No vomiting rate during synchronous radiotherapy and chemotherapy
Time frame: 1 month
The rate of non emergency medication during synchronous radiotherapy and chemotherapy
Time frame: 1 month
The prevalence and severity of oral/oropharyngeal mucositis during synchronous radiotherapy and chemotherapy
Time frame: 1 month
Successful rescue rate of breakthrough vomiting: (defined as no vomiting within 48 hours)
Time frame: 1 month
Evaluate the impact of medication on patients' daily activities of life (evaluated based on the nausea and vomiting questionnaire FLIE)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Netopitam Palonosetron capsules and dexamethasone in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Sichuan Cancer Hospital and Research Institute 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 26 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangkun Luo (13518161979, 621199521@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete response rate during synchronous radiotherapy and chemotherapy (defined as no vomiting episodes and no emergency medication). (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.