Cervical cancer
Conditions
Interventions
NEPA DEX Group:NEPA: Take 1 capsule of netupitampalonosegron about 1 hour before chemotherapy every week.
Dexamethasone: 12 mg intravenously about 30 minutes before the weekly chemotherapy course, 4 m
NEPA DEX reduction group:NEPA: Take 1 capsule of netupitampalonosegron about 1 hour before chemotherapy every week.
Dexamethasone: 12 mg intravenously about 30 minutes before the weekly course of chem
NEPA DEX Alternating Group:NEPA: Take 1 capsule of netupitampalonosegron about 1 hour before chemotherapy every week.
Dexamethasone: 12 mg intravenously about 30 minutes before a single week of chemot
Sponsors
Cancer Hospital Affiliated to Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age >= 18 years; 2. Patients with cervical cancer after radical resection confirmed by histopathological diagnosis; 3. Patients who intend to receive concurrent chemoradiotherapy (single-week cisplatin radiotherapy); 4. ECOG score of physical status=3 months; 6. Participants voluntarily and strictly comply with the requirements of the study protocol and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a benign disease that causes nausea and vomiting for a long time in the past; 2. Central nervous system diseases (such as epilepsy, brain tumors); 3. Receipt of any known or potential antiemetic medication within 24 hours prior to Day 1 or symptoms of vomiting, retching, or mild nausea within 24 hours prior to Day 1; 4. Pregnant or lactating women; 5. Use of CYP3A4 inducers within 4 weeks and CYP3A4 substrates or strong, moderate CYP3A4 inhibitors within 1 week prior to study initiation; 6. Hypocalcemia or any other condition that may cause vomiting; 7. Factors that obviously affect the absorption of oral drugs, such as chronic diarrhea and intestinal obstruction; 8. Participant has an allergic reaction to netupitan palonostron capsules or any of their excipients; 9. Patient with case record who has participated in any other clinical study of an investigational drug or medical device within 30 days prior to medication, except for observational studies; 10. In the opinion of the investigator, there are any other factors that are not suitable for inclusion or affect participation in or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete remission (no vomiting and no rescue treatment) during the risk period;Proportion of patients with complete remission (no vomiting and no rescue treatment) in the acute, delayed phases;The degree of impact of nausea and vomiting in the acute, delayed, and risk phases on the patient's daily living activities (Vomiting Life Function Index Questionnaire (FLIE) assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete control (no vomiting, no rescue treatment, no slight nausea (VAS<25mm)) in the acute, delayed, and risk phases;Proportion of patients without vomiting in the acute, delayed, and at-risk phases;Proportion of patients receiving rescue treatment in the acute, delayed, and risk phases; | — |
Countries
China
Contacts
Public ContactLi Jiehui
Affiliated Cancer Hospital of Guizhou Medical University
Outcome results
None listed