Back to resultsFosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fosaprepitant , Tropisetron and Olanzapine
Fosaprepitant , Tropisetron, Dexamethasone and Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting focused on measuring Nausea, Vomiting, Glucocorticoids, Olanzapine, Tropisetron, Fosaprepitant, Signs and Symptoms, Digestive, Antiemetics, Physiological Effects of Drugs
Eligibility Criteria
Inclusion Criteria:
1.18-70 years of age; 2.Histologically or cytologically confirmed breast cancer; 3.Accept chemotherapy for the first time; 4.Must be able to swallow tablets 4.Anthracycline/Cyclophosphamide-containing chemotherapy (adriamycin in combination with cyclophosphamide ,cyclophosphamide ≤ 600mg/m2, adriamycin ≤ 60mg/m2, epirubicin ≤ 100mg/m2); 5.Written informed consent.
Exclusion Criteria:
- Mentally disable or suffered from emotional disorders;
- Insulin dependent diabetes；
- Pregnant or breastfeeding;
- Suffered from vomiting or nausea in the 24 hours before treatment;
- Narrow angle glaucoma；
- Receive the following antiemetic agents within 48 hours before the first day of treatment: 5-hydroxytryptamine 3 receptor antagonists (such as ondansetron), phenothiazines, benzophenones (such as haloperidol), benzamide , domperidone, cannabinoids, herbs with potential antiemetic effects, scopolamine, and cyclizine, etc;
- Receive benzodiazepines or opioids within 48 hours prior to the first day of the study (except for triazolam, temazepam or midazolam single dose daily);
- Symptomatic primary or metastatic central nervous system malignancies;
- Hypersensitivity to fosaprepitant, olanzapine, tropisetron or dexamethasone;
- History of concurrent abdominal radiotherapy;
Sites / Locations
- Henan cacer hospitalRecruiting
- Henan cancer hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard antiemetic therapy without dexamethasone
Standard antiemetic therapy
Arm Description
Olanzapine in combination with fosaprepitant and tropisetron
Olanzapine in combination with fosaprepitant, tropisetron and dexamethasone
Outcomes
Primary Outcome Measures
complete response rate in the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) phase.
Complete response is defined as a condition in which a patient does not show vomiting or retching and does not require additional treatment with antiemetics. Retching is defined as the physical reaction that accompanies vomiting in the absence of gastric content ejection.
Secondary Outcome Measures
Complete control rate during the overall phase
Complete control is defined as a condition where a patient shows no nausea or mild nausea
Total control rate during the overall phase
Total control is defined as a condition where a patient neither shows nausea nor vomiting.
To compare quality of life using the functional living index-emesis questionnaire
No (or minimal) Impact on patient's Daily Life (NIDL) is generally considered a score ≥54 (6 points mean for each item)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05242874
Brief Title
Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer
Official Title
Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Standard antiemetic therapy without dexamethasone for the prevention of nausea and vomiting in patients with breast cancer
Detailed Description
This is a multicenter, randomized, controlled, open-label, phase III study assessing the efficacy and safety of fosaprepitant, tropisetron and olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy. Eligible patients will be randomized to receive either standard antiemetic therapy (fosaprepitant, tropisetron, dexamethasone and olanzapine) or standard antiemetic therapy without dexamethasone in a 1:1 ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
Keywords
Nausea, Vomiting, Glucocorticoids, Olanzapine, Tropisetron, Fosaprepitant, Signs and Symptoms, Digestive, Antiemetics, Physiological Effects of Drugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
403 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard antiemetic therapy without dexamethasone
Arm Type
Experimental
Arm Description
Olanzapine in combination with fosaprepitant and tropisetron
Arm Title
Standard antiemetic therapy
Arm Type
Active Comparator
Arm Description
Olanzapine in combination with fosaprepitant, tropisetron and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant , Tropisetron and Olanzapine
Other Intervention Name(s)
Standard antiemetic therapy without dexamethasone
Intervention Description
fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. tropisetron 5mg i.v. on day 1 before undergoing chemotherapy. olanzapine 5mg p.o. on day 1-4
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant , Tropisetron, Dexamethasone and Olanzapine
Other Intervention Name(s)
Standard antiemetic therapy
Intervention Description
On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.
fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. tropisetron 5mg i.v. on day 1 before undergoing chemotherapy. olanzapine 5mg p.o. on day 1-4
Primary Outcome Measure Information:
Title
complete response rate in the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) phase.
Description
Complete response is defined as a condition in which a patient does not show vomiting or retching and does not require additional treatment with antiemetics. Retching is defined as the physical reaction that accompanies vomiting in the absence of gastric content ejection.
Time Frame
Day 1 to day 5 after highly emetogenic chemotherapy initiation
Secondary Outcome Measure Information:
Title
Complete control rate during the overall phase
Description
Complete control is defined as a condition where a patient shows no nausea or mild nausea
Time Frame
Day 1 to day 5 after highly emetogenic chemotherapy initiation
Title
Total control rate during the overall phase
Description
Total control is defined as a condition where a patient neither shows nausea nor vomiting.
Time Frame
Day 1 to day 5 after highly emetogenic chemotherapy initiation
Title
To compare quality of life using the functional living index-emesis questionnaire
Description
No (or minimal) Impact on patient's Daily Life (NIDL) is generally considered a score ≥54 (6 points mean for each item)
Time Frame
Day 1 to day 5 after highly emetogenic chemotherapy initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.18-70 years of age; 2.Histologically or cytologically confirmed breast cancer; 3.Accept chemotherapy for the first time; 4.Must be able to swallow tablets 4.Anthracycline/Cyclophosphamide-containing chemotherapy (adriamycin in combination with cyclophosphamide ,cyclophosphamide ≤ 600mg/m2, adriamycin ≤ 60mg/m2, epirubicin ≤ 100mg/m2); 5.Written informed consent.
Exclusion Criteria:
Mentally disable or suffered from emotional disorders;
Insulin dependent diabetes；
Pregnant or breastfeeding;
Suffered from vomiting or nausea in the 24 hours before treatment;
Narrow angle glaucoma；
Receive the following antiemetic agents within 48 hours before the first day of treatment: 5-hydroxytryptamine 3 receptor antagonists (such as ondansetron), phenothiazines, benzophenones (such as haloperidol), benzamide , domperidone, cannabinoids, herbs with potential antiemetic effects, scopolamine, and cyclizine, etc;
Receive benzodiazepines or opioids within 48 hours prior to the first day of the study (except for triazolam, temazepam or midazolam single dose daily);
Symptomatic primary or metastatic central nervous system malignancies;
Hypersensitivity to fosaprepitant, olanzapine, tropisetron or dexamethasone;
History of concurrent abdominal radiotherapy;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhen Liu
Phone
13603862755
Email
liuzhenzhen73@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dechuang Jiao
Phone
13598004327
Email
jiaodechuang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhen Liu
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan cacer hospital
City
Henan
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Zhen
Phone
13838308034
Facility Name
Henan cancer hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenzhen Liu
Phone
13603862755
Email
liuzhenzhen73@126.com
12. IPD Sharing Statement
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Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer
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