UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054250 |
|---|---|
| Receipt number | R000061951 |
| Scientific Title | A prospective observational study on the optimization of four-drug antiemetic therapy including fosnetupitant and olanzapine for perioperative epirubicin-cyclophosphamide therapy in breast cancer |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/02/14 18:14:28 |
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Basic information
Public title
A study on antiemetic drugs in breast cancer chemotherapy
Acronym
A study on antiemetic drugs in breast cancer chemotherapy
Scientific Title
A prospective observational study on the optimization of four-drug antiemetic therapy including fosnetupitant and olanzapine for perioperative epirubicin-cyclophosphamide therapy in breast cancer
Scientific Title:Acronym
A prospective observational study on the optimization of four-drug antiemetic therapy including fosnetupitant and olanzapine for perioperative epirubicin-cyclophosphamide therapy in breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the effectiveness of a four-drug therapy comprising fosnetupitant, palonosetron, dexamethasone, and olanzapine for the primary prevention of chemotherapy-induced nausea and vomiting(CINV) in perioperative epirubicin-cyclophosphamide therapy for breast cancer.
Additionally, we aim to explore the rate of CINV control in patients who experienced intolerance to standard-dose olanzapine and had their olanzapine does reduce or discontinued in the second course.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
No nausea during the overall assessment period (0 to 120 hours) on the first course
Key secondary outcomes
1. Complete response
2. Complete control
3. Total control
4. Time to treatment failure
5. Daytime somnolence
6. Change in dosage of olanzapine
7. Satisfaction with antiemetic therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1. Early-stage or locally advanced breast cancer.
2. No prior chemotherapy and scheduled to receive epirubicin and cyclophosphamide (EC) or dose-dense EC therapy.
3. ECOG Performance Status 0 or 1.
Key exclusion criteria
1. Concurrent use of antiemetic agent.
2. Start of opioid analgesic for 14 days before registration.
3. Subjects on anticonvulsant therapy.
4. Gastrointestinal obstruction (e.g. gastropyloric stenosis, intestinal obstruction).
5. Diagnosis of diabetes mellitus(e.g., on insulin or an oral hypoglycemic agent).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shimizu |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Pharmacy
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
TEL
092-541-3231
shimizu.hiroaki.bc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Higuchi |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Pharmacy
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
TEL
092-541-3231
Homepage URL
higuchi.ayako.jn@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center Ethics Committee
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
Tel
092-541-3231
601-rinri@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
Single-center prospective cohort observational study with patient's self-written daily diary for symptoms.
Participants
Patients admitted to the Kyushu Cancer Center in Japan for epirubicin-cyclophosphamide therapy, who meet the eligibility criteria and do not meet the exclusion criteria.
Management information
Registered date
| 2024 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061951
