UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of improvement effect of postoperative persistent pain with a "healthy life expectancy stretched box"
Title of the study (Brief title)	Postoperative persistent pain and healthy life expectancy stretched box
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To target the patients with postoperative persistent pain, we will investigate effective of healthy life expectancy stretched box for improving cancer pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain assessment by NRS and QOL assessment by the SF-36 ver.2 and evaluation of the stress level of patients by the salivary amylase monitor. we will assess before and after to enter the healthy life expectancy stretched box
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Before healthy extension life box admission, we will measure pain evaluation and the QOL evaluation, a saliva amylase level of the patient.We will let patients enter the healthy life expectancy extension box. We will measure pain evaluation and the saliva amylase level after box admission. We will let patients enter the healthy life expectancy extension box after 2~3 day. We will measure pain evaluation and the saliva amylase level after box admission. After 2~3 days, healthy extension life box admission, we will measure pain evaluation and the QOL evaluation, a saliva amylase level of the patient.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Tumor-bearing patients under 20 years of age or 75 years of age. Patients who are received a diagnosis of postoperative persistent pain. Patients who are the intensity of the pain of 3-8 in the numerical rating scale (NRS). After receiving a sufficient explanation upon participation in this study, patients who consent was obtained by the document based on the free will of the patient himself.
Key exclusion criteria	Patients complain of difficulty breathing. Patients with pleural effusion or ascites requiring drainage. Patients with history for ischemic heart disease and aortic valve stenosis of heart failure, obstructive hypertrophic cardiomyopathy. Patients with a history of cooped-up feeling and breathing difficulties in the sauna entrance. Female patient of pregnant or lactating.
Target sample size	17

Research contact person
Name of lead principal investigator	Maruyama Yuki
Organization	Shinshu university school of medicine
Division name	The department of Anesthesiology and Resuscitology
Address	Matsumoto, Nagano Prefecture Asahi 3-1-1
TEL	0263-37-2670
Email	yukio.afternoon.tea@gmail.com

Public contact
Name of contact person	Maruyama Yuki
Organization	Shinshu university school of medicine
Division name	The department of Anesthesiology and Resuscitology
Address	Matsumoto, Nagano Prefecture Asahi 3-1-1
TEL	0263-37-2670
Homepage URL
Email	yukio.afternoon.tea@gmail.com

Sponsor
Institute	Department of comprehensive cancer therapy, Shinshu university school of medicine
Institute
Department

Funding Source
Organization	Department of comprehensive cancer therapy, Shinshu university school of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Ltd. Water Life

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 12 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 13 Day
Anticipated trial start date	2015 Year 12 Month 16 Day
Last follow-up date	2018 Year 12 Month 01 Day
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

Management information
Registered date	2015 Year 12 Month 16 Day
Last modified on	2018 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023345