UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004728 |
|---|---|
| Receipt number | 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 09:44:57 |
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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
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
tashinoz@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005481
