UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Aprepitant for Hematology and Oncology.
Acronym	Efficacy of Aprepitant for Hematology and Oncology.
Scientific Title	Efficacy of Aprepitant for Hematology and Oncology.
Scientific Title:Acronym	Efficacy of Aprepitant for Hematology and Oncology.
Region	Japan

Condition
Condition	Hematological cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In the first step , We investigate a situation of nausea and vomiting and anorexia in patients receiving chemotherapy for blood-tumor. Next step, we evaluate the efficacy of aprepitant in patients who induced nausea and vomiting and anorexia in the first step. In addition, we assess the influence aprepitant on antitumor effect in patients administred steroids as cancer chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The difference of the incidence of nausea and vomiting
Key secondary outcomes	The proportion of patients with Complete Response (no emesis and no rescue therapy) in the overall phase (0-120 hour after administration of antitumor agent). The proportion of patients with Complete Response ( no emesis and no rescue therapy ) in Day 1 or Day 2 - Day 5.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	aprepitant(d1-3)
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	Male and Female
Key inclusion criteria	1. Received the chemotherapy for blood tumor 2. able to record the onset of vomiting and nausea in a symptom diary 3. patients who induced nausea and vomiting and anorexia and rescue therapy in the first chemotherapy. 4. Performance Status(PS) of 0-2 5. estimated life expectancy of at least 3 months 6. aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase (GOT)) and alanine aminotransferase(ALT) (glutamic pyruvic transaminase (GPT))<2.5 x upper limit of the normal range at the facility 7. total bilirubin <1.5 x upper limit of the normal range at the facility 8. creatinine <1.5 x upper limit of the normal range at the facility
Key exclusion criteria	1. chemotherapy within 6 days before study day 1 or between days 1 to 6. 2. Antiemetic therapy prior to 48 hr of chemotherapy. 3. Corticosteroids therapy within 72 hr before study day 1 or duration of study 4. Radiation therapy to the abdomen or pelvis within 6 days before study day 1 or duration of study 5. known central nervous system malignancy 6. following drug therapy within 6 days before study day 1 - clarithromycin, ketoconazole, itraconazole - 7. following drug therapy within 4 weeks before study day 1 - barbiturate, rifampicin, phenytoin, carbamazepine - 8. pregnant, nursing or possibly pregnant women 9. Patients judged inappropriate for this study by physicians
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Akifumi Middle name Last name Takaori-Kondo
Organization	Kyoto University Hospital
Division name	Department of Hematology and Oncology
Zip code	606-8507
Address	54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL	075-751-3150
Email	atakaori@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tadakazu Middle name Last name Kondo
Organization	Kyoto University Hospital
Division name	Department of Hematology and Oncology
Zip code	606-8507
Address	54 Kawaramachi, Seigoin, Sakyo-ku, Kyoto-shi, Kyoto
TEL	075-366-7550
Homepage URL
Email	tadakazu@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital,Department of Hematology and Oncology
Institute
Department

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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 07 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	52
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	Completed
Date of protocol fixation	2011 Year 07 Month 15 Day
Date of IRB	2013 Year 01 Month 21 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2014 Year 01 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 06 Month 01 Day
Last modified on	2022 Year 06 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006746