UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041605 |
|---|---|
| Receipt number | R000045429 |
| Scientific Title | The evaluation of delayed CINV for the breast cancer patients during adjuvant dose-dense AC with steroid sparing and olanzapine 5mg regimen: A single center pilot study |
| Date of disclosure of the study information | 2020/08/29 |
| Last modified on | 2022/03/01 09:31:58 |
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Basic information
Public title
The evaluation of delayed CINV for the breast cancer patients during adjuvant dose-dense AC with steroid sparing and olanzapine 5mg regimen: A single center pilot study
Acronym
The evaluation of delayed CINV for the breast cancer patients during adjuvant dose-dense AC with steroid sparing and olanzapine 5mg regimen: A single center pilot study
Scientific Title
The evaluation of delayed CINV for the breast cancer patients during adjuvant dose-dense AC with steroid sparing and olanzapine 5mg regimen: A single center pilot study
Scientific Title:Acronym
The evaluation of delayed CINV for the breast cancer patients during adjuvant dose-dense AC with steroid sparing and olanzapine 5mg regimen: A single center pilot study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the complete response rate (CR rate) of delayed emesis during steroid sparing with olanzapine in breast cancer perioperative dose-dense AC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CR rate in the delayed phase (24-120 hours after dose-dense AC)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Patients diagnosed with operable breast cancer
2) Patients in stages I-III.
3) Patients who are judged by their physicians to be eligible for dose-dense AC therapy (ddAC) as adjuvant perioperative chemotherapy.
(4) Written informed consent, with the understanding that the patient may withdraw consent at any time without prejudice.
Key exclusion criteria
1) Patients with contraindications to olanzapine (patients with a history of diabetes)
2) Patients considered to be inappropriate for the study participation, as judged by the primary physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manami |
| Middle name | |
| Last name | Tada |
Organization
Kansai Medical University Hospital
Division name
Department of Breast Surgery
Zip code
573-1191
Address
Shinmachi 2-3-1, Hirakata City, Osaka, Japan
TEL
0728040101
mnm.noa527@gmail.com
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | Kikawa |
| Last name | Tada |
Organization
Kansai Medical University Hospital
Division name
Department of Breast Surgery
Zip code
573-1191
Address
Shinmachi 2-3-1, Hirakata City, Osaka, Japan
TEL
0728040101
Homepage URL
mnm.noa527@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Osaka
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital
Address
Shinmachi 2-3-1, Hirakata City, Osaka, Japan
Tel
0728040101
kmuinfo@hirakata.kmu.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items will be surveyed and their data will be used in this study. All of these items will be conducted in daily practice, and their frequency will be the same as in routine practice.
1) Basic information about the study subjects: age, gender, diagnosis, height, and weight.
2) Hematological tests: hemoglobin, white blood cell count, white blood cell fraction, platelet count
3) Blood biochemical tests: ALP, total bilirubin, albumin, AST, ALT, total protein, LDH, creatinine, BUN, Na, K, Cl
4) Assessment of nausea and vomiting
The number of vomiting events (emesis or vomiting) is assessed on a 4-point scale of 0, 1, 2, and 3 or more times every 24 hours starting at the time of ddAC administration and ending 120 hours later.
The level of nausea is assessed every 24 hours starting at the time of ddAC administration up to 120 hours later on a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe).
Evaluation of the number of additional antiemetic use
VAS is used to assess the degree of nausea and vomiting every 24 hours starting at the time of ddAC administration and continuing until 120 hours later.
PRO-CTCAE (ver. 1.0 JCOG) was used to evaluate "Anorexia," "Nausea," and "Vomiting" on Day 1 and 8 of Cycle 1 and on Day 1 of Cycle 2.
5) Daytime sleepiness assessment
Starting at the start of ddAC administration and continuing up to 120 hours later, the degree of daytime sleepiness is rated on a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe) every 24 hours
6) Bone density measurement
DXA measurements at the lumbar spine and femoral neck bone prior to initiation of ddAC (within 2 weeks) and on the date of the last cycle of adjuvant therapy, including taxane (+/-1 week)
Management information
Registered date
| 2020 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045429
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