UMIN-CTR Clinical Trial

Basic information
Public title	Study of efficacy and safety of oral neurokinin-1 antagonist, aprepitant for prevention of chemotherapy-induced nausea and vomiting associated with 5-FU/cisplatin chemotherapy in patients with head and neck cancer.
Acronym	Effect of aprepitant in patients with head and neck cancer receiving 5-FU/cisplatin chemotherapy.
Scientific Title	Study of efficacy and safety of oral neurokinin-1 antagonist, aprepitant for prevention of chemotherapy-induced nausea and vomiting associated with 5-FU/cisplatin chemotherapy in patients with head and neck cancer.
Scientific Title:Acronym	Effect of aprepitant in patients with head and neck cancer receiving 5-FU/cisplatin chemotherapy.
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of aprepitant 5-days regimen with 5-HT3 receptor antagonist and dexamethasone in patients with head and neck cancer receiving 5-FU/cisplatin chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The proportion of patients with Complete Response (no vomiting and no use of rescue therapy) in overall phase (8 days after administration of cisplatin on day 1)
Key secondary outcomes	1) The proportion of patients with Complete Response in acute phase (days 1 to 4 after administration of cisplatin on day 1) and delayed phase (days 5 to 8 after administration of cisplatin on day 1) 2) The proportion of patients with no vomiting in overall, acute, and delayed phase 3) The frequency of nausea and vomiting 4) Food Intake

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aprepitant 125 mg PO on day 1 Aprepitant 80 mg PO on days 2 to 5 Granisetron 3 mg IV on days 1 to 4 Dexamethasone 8 mg IV on days 1 to 4
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) Patient is scheduled to receive his/her first course of 5-FU/cisplatin chemotherapy for head and neck cancer 2) Patient has not received highly or moderately emetogenic chemotherapy 3) Performance Status : 0-2
Key exclusion criteria	1) Patient has a serious hepatic insufficiency or renal failure 2) Patient has nausea or vomiting within 24 hours prior to chemotherapy 3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy 4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 5) Patient is scheduled to receive radiation therapy to the abdomen 6) Patient is judged inappropriate by the investigator as subject for this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kotaro Ishimaru
Organization	Nagasaki University Hospital
Division name	Department of otolaryngology
Zip code
Address	1-7-1 sakamoto, Nagasaki, Japan
TEL	095-819-7349
Email	kishimar@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kotaro Ishimaru
Organization	Nagasaki University Hospital
Division name	Department of otolaryngology
Zip code
Address	1-7-1 sakamoto, Nagasaki, Japan
TEL	095-819-7349
Homepage URL
Email	kishimar@nagasaki-u.ac.jp

Sponsor
Institute	Department of otolaryngology , Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Department of otolaryngology , Nagasaki University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2011 Year 02 Month 15 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	No longer recruiting
Date of protocol fixation	2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 02 Month 12 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005977