UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Frequency of Myofascial Pain Sydrome In Incurable Cancer Patients Receiving Palliative Care.A Multi-Center, Observational Study.
Title of the study (Brief title)	MyCar study
Region	Japan

Condition
Condition	Incurable cancer
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the frequency and risk factors of myofascial pain syndrome (MPS) in cancer patients during palliative care intervention.
Basic objectives2	Others
Basic objectives -Others	MPS frequency (according to Simons' diagnostic criteria) Presence / absence of device Correlation between device position and MPS position Correlation between surgical history and MPS frequency Correlation between PS (performance status) and MPS frequency The response rate of Trigger point block injection (TPI) Presence or absence of MPS and the relationship between alexithymia, depression and anxiety Frequency of extensive chronic pain in cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of MPS (Diagnostic criteria of Rivers)
Key secondary outcomes	MPS frequency (according to Simons' diagnostic criteria) Presence / absence of device Correlation between device position and MPS position Correlation between surgical history and MPS frequency Correlation between PS (performance status) and MPS frequency The response rate of Trigger point block injection (TPI) Presence or absence of MPS and the relationship between alexithymia, depression and anxiety Frequency of extensive chronic pain in cancer patients

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) Inpatients planned for intervention by palliative care teams or patients expected to be admitted to palliative care units 2) Cancer is announced 3) Patients with non-curable solid cancers 4) Age at registration is over 20 years old 5) Average NRS of pain 24 hours before registration is greater than 4 or 4 6) Blood and biochemical test data within 2 weeks of registration are available
Key exclusion criteria	1) consciousness disorder, pain assessment is impossible
Target sample size	200

Research contact person
Name of lead principal investigator	Hiroto Ishiki
Organization	National Cancer Center Hospial
Division name	Department of Palliative Medicine
Address	5-1-1 Tsukiji , Chuo-Ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Email	ishiki-tky@umin.ac.jp

Public contact
Name of contact person	Junya Kinkawa
Organization	IMSUT Hospital
Division name	Joint Surgery
Address	4-6-1, Shirokanedai, Minato-Ku,Tokyo 108-8639, Japan
TEL	03-3443-8111
Homepage URL
Email	kinspoint@gmail.com

Sponsor
Institute	National Cancer Center Hospial
Institute
Department

Funding Source
Organization	Japanese Society for Palliative Medicine Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 02 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Estimate accurate 95% confidence intervals based on the proportion of MPS in all cases and binomial distribution.

Management information
Registered date	2018 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035745