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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019810
Receipt No. R000022844
Scientific Title The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Date of disclosure of the study information 2015/11/16
Last modified on 2019/02/21

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Basic information
Public title The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Acronym The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Scientific Title The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Scientific Title:Acronym The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Region
Japan

Condition
Condition Extrapyramidal Symptoms
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the frequency of extrapyramidal symptoms In cancer patients who receive palliative care.
Basic objectives2 Others
Basic objectives -Others The frequency of extrapyramidal symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DIEPSS
Key secondary outcomes LUNSERS EPS subscale, CAM, drug utilization

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) Patients who are planned to receive intervention by palliative care teams or to be hospitalized in palliative care units
2) Cancer patients who were informed of their diagnosis
3) Patients who are aged 20 years or older
Key exclusion criteria Not specified
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Ishiki
Organization Research Hospital of the Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL 03-3443-8111
Email ishiki-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroto Ishiki
Organization Research Hospital of the Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL 03-3443-8111
Homepage URL
Email ishiki-tky@umin.ac.jp

Sponsor
Institute Research Hospital of the Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
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
2015 Year 11 Month 16 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
2015 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information - Prospective observational study
- Consecutive patients who visit the institutions and meet eligible criteria during one month after approval of institutional review board between Oct. 2015 and Sep. 2016.
- DIEPSS (Drug-induced extrapyramidal symptoms scale), LUNSERS (The Liverpool University Neuroleptic Side Effect Rating Scale), CAM (Confusion Assessment Method)

Management information
Registered date
2015 Year 11 Month 16 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022844

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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