UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008080 |
|---|---|
| Receipt number | 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 14:43:57 |
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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
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
uedatsu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital Department of Otorhinolaryngology Head and Neck Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008312
