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Trial 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
NCT ID:
NCT06102447
Condition:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Vomiting
Dexamethasone
Palonosetron
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Netopitam Palonosetron capsules and dexamethasone
Description:
On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone
to reduce the incidence of acute vomiting.
Arm group label:
Treatment Group
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, aged 18-75 years old;
2. Head and neck tumors confirmed by histology or cytology (including oral cancer,
oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer);
3. Receive radical synchronous radiotherapy and chemotherapy;
4. The Eastern Oncology Collaborative Group (ECOG) physical fitness score of the
subjects was ≤ 2 points;
5. Adequate organ and bone marrow function;
6. The expected life is at least 12 weeks;
7. Pregnant or fertile patients (male or female) use reliable contraceptive measures;
8. When screening female patients with potential pregnancy, the pregnancy test must be
negative;
9. The subjects voluntarily and strictly comply with the requirements of the research
protocol and sign a written informed consent form.
Exclusion Criteria:
1. Recurrent and metastatic head and neck tumors;
2. Previously underwent tumor resection surgery for treatment;
3. Patients with platinum drug intolerance;
4. 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;
5. Take NK1（neurokinin-1） receptor antagonists or any study medication within 4 weeks
before the start of the experiment;
6. Use CYP3A4 inducer within 4 weeks before chemotherapy, and use CYP3A4 substrate or
strong or moderate CYP3A4 inhibitor within 1 week;
7. Serious cardiovascular, pulmonary, diabetes, mental and other diseases;
8. Pregnant or lactating women, patients with fertility who are unwilling or unable to
take effective contraceptive measures;
9. Drug and/or alcohol abuse;
10. Hypocalcemia or any other condition that may cause vomiting;
11. There are significant factors that affect the absorption of oral medication, such as
chronic diarrhea and intestinal obstruction;
12. The subject has allergic reactions to Netopitam Palonosetron capsules or any of
their excipients;
13. 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;
14. The researcher determines other situations that may affect the progress of clinical
research and the determination of research results.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sichuan Cancer Hospital and Research Institute
Address:
City:
Chengdu
Zip:
610041
Country:
China
Start date:
November 1, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102447
