UMIN-CTR Clinical Trial

Basic information
Public title	Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.
Acronym	Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting.
Scientific Title	Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.
Scientific Title:Acronym	Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting.
Region	Japan

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

Objectives
Narrative objectives1	Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Complete response rate of vomiting within 120hours from cisplatin administration
Key secondary outcomes	(a)Complete response rate of vomiting within 24hours,and 24-120 hours from cisplatin administration. (b)Level of nausea (c)Level of anorexia (d)The proportion of patients receiving rescue medication. (e)Evaluation of nausea and vomiting of each course on 10 point scale. (f)adverse event

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Fosaprepitant 150mg, iv (Day 1) Palonosetron 0. 75mg, iv (Day 1) Dexamethasone 9.9 mg, iv (Day 1) Dexamethasone 6.6 mg, iv (Days 2-4)
Interventions/Control_2	Fosaprepitant 150mg, iv (Day 1) Palonosetron 0. 75mg, iv (Day 1) Dexamethasone 3.3 mg, iv (Days 1-4)
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	Male and Female
Key inclusion criteria	(a) From 20 or more to 75 years old or less at time of registration. (b) Patients who receive the chemotherapy by two courses involving cisplatin as first line. (c) ECOG PS of patients is 0-2. (d) Patients will provide written informed consent.
Key exclusion criteria	(a) Vomiting prior to chemotherapy within 24hours (b) They have the factor (tumor of the brain, street trouble of the gut, ulcus pepticum of briskness, and cerebral metastasis, etc.) that nausea and vomiting are caused besides the cancer chemotherapy (c) They have an associated symptom (ex infectious disease) patient who cannot administer dexamethasone. (d) judged by the investigator to be inappropriate for this study (e) pimozide is being administered.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Katsuhiro Middle name Last name Hirakawa
Organization	Hiroshima University Hospital
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Zip code	7348551
Address	Kasumi 1-2-3 Minami-ku, Hiroshima
TEL	082-257-5252
Email	katsuhw@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Ueda
Organization	Hiroshima University Hospital
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Zip code	7348551
Address	Kasumi 1-2-3 Minami-ku, Hiroshima
TEL	082-257-5252
Homepage URL
Email	uedatsu@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital Department of Otorhinolaryngology Head and Neck Surgery
Institute
Department

Funding Source
Organization	Hiroshima University Hospital Department of Otorhinolaryngology Head and Neck Surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hiroshima University Ethics Review Board
Address	Kasumi 1-2-3 Minami-ku, Hiroshima
Tel	082-257-5596
Email	hugcp@hiroshima-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

Other administrative information
Date of disclosure of the study information	2012 Year 06 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	Completed
Date of protocol fixation	2011 Year 10 Month 18 Day
Date of IRB	2012 Year 05 Month 31 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 06 Month 01 Day
Last modified on	2019 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008312