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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001048
Receipt No. R000000941
Scientific Title The multicenter phase II study of opioid based pain control program for head and neck cancer patients recieving chemoradiotherapy
Date of disclosure of the study information 2008/03/01
Last modified on 2012/10/19

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Basic information
Public title The multicenter phase II study of
opioid based pain control program for head and neck cancer patients recieving chemoradiotherapy

Acronym SCHN-A001
Scientific Title The multicenter phase II study of
opioid based pain control program for head and neck cancer patients recieving chemoradiotherapy

Scientific Title:Acronym SCHN-A001
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Medicine in general Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and safety of opioid based pain control program for head and neck cancer treated with chemoradiotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The frequency of treatment interruption caused by severe stmatitis or mucocitis
Key secondary outcomes the rate of completion of radiotherapy

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 Opioid based pain control program
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. be to recieve chemoradiotherapy including over 50 Gy irradiation for pharyngeal/ oral space
2. be to recieve treatment without radiation split over 1week
3. age:20-75
4. ECOG PS:0-1
5.adequate bone marrow fanction, laboratory parameters, hepatic fanction and renal fanction
Key exclusion criteria 1 women who are pregnant or breast feeding
2 with mental disorder
3 recieve the systemic therapy of steroid continuously
4 have the history of Miocardial infarction within 3 months
5 recieve the opioid therapy for cancer pain
6 with sever active co-mobidity (COPD, interstitial pneumonitis, angina pectoris and so on)
7 with severe infectious disease
8 do not agree with constructing PEG
9 with collagenosis
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao
Organization National Cancer Center Hospital
Division name Head and Neck Surgery
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL 0
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sadamoto Zenda
Organization National Cancer Center Hospital East
Division name Radiation Oncology Division
Zip code
Address 6-5-1 kashiwanoha Kashiwa city chiba, Japan
TEL 04-7133-1111
Homepage URL
Email szenda@east.ncc.go.jp

Sponsor
Institute Study for establishment of prevention and therapy of oral complication induced by cancer treatment
Institute
Department

Funding Source
Organization Grant-in-aid for cancer research
Organization
Division
Category of Funding Organization
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
2008 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 02 Month 22 Day
Last modified on
2012 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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