UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Title of the study (Brief title)	Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Region	Japan

Condition
Condition	patients passing more than 6 months after breast cancer surgery
Classification by specialty	Breast surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims to find the factors around peri-operative period causing chronic pain after breast cancer
Basic objectives2	Others
Basic objectives -Others	risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of chronic pain(continued more than 6 months after surgery)
Key secondary outcomes	Severity of chronic pain(continued more than 6 months after surgery)

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	70 years-old >=
Gender	Female
Key inclusion criteria	female under 70 years old patients undergoing surgery in 3 years
Key exclusion criteria	over 70 years old male bilateral surgery at once unilateral surgery with reconstruction or insertion of expander ASA class 3 over emergent surgery analgesic user antipsychotic or anxiolytic drug user BMI over 35 eGFR under 50 patients diagnosed cancer recurrence or metastasis during post-operative periods death patients followed up by other doctors
Target sample size	300

Research contact person
Name of lead principal investigator	Tomoyuki Miyazaki
Organization	Yokohama city University, Sch. Medicine
Division name	Dept. Anesthesiology
Address	3-9 fukuura, kanazawa-ku,yokohama city, japan
TEL	045-787-2918
Email	johney4@hotmail.com

Public contact
Name of contact person	Tomoyuki Miyazaki
Organization	Yokohama city University, Sch. Medicine
Division name	Dept. Anesthesiology
Address	3-9 fukuura, kanazawa-ku,yokohama city, japan
TEL	045-787-2918
Homepage URL
Email	johney4@hotmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Other
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	2014 Year 09 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 08 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	prospective cross-sectional study

Management information
Registered date	2014 Year 09 Month 05 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017444