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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004728
Receipt No. R000005481
Scientific Title Symptom prevalence and functional status among patients with advanced head and neck cancer: The observational study
Date of disclosure of the study information 2011/01/01
Last modified on 2014/06/16

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Basic information
Public title Symptom prevalence and functional status among patients with advanced head and neck cancer:
The observational study
Acronym Symptom prevalence with advanced head and neck cancer
Scientific Title Symptom prevalence and functional status among patients with advanced head and neck cancer:
The observational study
Scientific Title:Acronym Symptom prevalence with advanced head and neck cancer
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 Assess the prevalence of symptom and functional status among patients with advanced head and neck cancer.
Basic objectives2 Others
Basic objectives -Others observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate overall QOL of advanced head and neck cancer with EORTC-QLQ-C15-PAL
Key secondary outcomes Evaluate subscale of EORTC QLQ-C15-PAL, amount of airway secretions, Typical symptoms of head and neck cancer

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Written informed consent
2. age > 19 y.o.
3. The patients diagnosed stage 4 head and neck carcinoma evaluated as incurable.
1) oral cancer
2) nasal cavity and paranasal cancer
3) nasopharyngeal cancer
4) oropharyngeal cancer
5) hypopharyngeal cancer
6) laryngeal cancer
7) thyroid cancer
8) salivary gland cancer
4. hospitalized patient
5. Exclude surgical, radiological or oncological treatments with the primary intent of tumor reduction in the 2 weeks prior to study.
6. clear consciousness
7. PS (ECOG) 3-4
Key exclusion criteria 1. renal failure (Cr>2.0mg/dL), heart failure (NYHA 2-4), liver failure (Total bil>2mg/dL)
2. liver cirrhosis, nephrotic syndrome, protein-losing syndrome
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Shinozaki
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Surgery
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 0471331111
Email tashinoz@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Shinozaki
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Surgery
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Homepage URL
Email tashinoz@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization MHLW (JAPAN)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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 01 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
2010 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The observational study

Management information
Registered date
2010 Year 12 Month 15 Day
Last modified on
2014 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005481

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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