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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041605
Receipt No. 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 2020/08/29

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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
Email 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
Email mnm.noa527@gmail.com

Sponsor
Institute Kansai Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 29 Day
Date of IRB
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
2020 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045429

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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