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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008080
Receipt No. R000008312
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.
Date of disclosure of the study information 2012/06/01
Last modified on 2019/06/08

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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/ctr_e/ctr_view.cgi?recptno=R000008312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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