UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Title of the study (Brief title)	Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Medicine in general Endocrinology and Metabolism Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the of Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Patient satisfaction at day 14 and day 28
Key secondary outcomes	Physician satisfaction at day 28 Pain degree at day 14 and day 28 4-level evaluation of Nausea, Vommiting, constipation, daytime drowsiness at day 14 and day 28

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	Advanced breast cancer patients with moderate to severe pain
Key exclusion criteria	Oxnorm Contraindications 1)Severe respiratory depression, severe COPD 2)During acute attack of bronchial asthma 3)Secondary cardiac failure of chronic pulmonary diseases 4)During convulsive state 5)Paralytic ileus 6)Hypersensitivity to a group of opium alkaloids 7)Hemorrhagic colitis 8)Bacterial diarrhea OneDuro Patch Contraindication 1)hypersensitivity to any of the ingredients of the product Careful Administration 2)Respiratory dysfunctions such as chronic lung diseases 3)Asthma 4)Severe bradyarrhythmia 5)Severe hepatic or renal dysfunction 6)Organic brain disorders such as intracranial hypertension, disturbed consciousness, coma or brain cancer 7)Skin diseases such as atopic dermatitis ieczema on adhesive site 8)40dgree or more fever 9)History of drug dependence 10)Pregnancy, nursing women 11)Within next 2 days before using Fentanyl patch, antagonists of opioid receptor such as Pentazocine or Buprenorphine etc. are administered or planned to administer 12)below the age of 20 13)Attending doctors judgement
Target sample size	90

Research contact person
Name of lead principal investigator	Kazushige Futsuhara
Organization	Saitama Medical Center Jichi medical Univercity
Division name	Depertment of Surgery
Address	1-847,Amanuma-cho,Omiya-kuSaitama-shiSaitama,Japan 330-0834
TEL	048-647-2111
Email	kazushige666@yahoo.co.jp

Public contact
Name of contact person	Toshihiro Kai
Organization	Shintoshin Ladies' Mammoclinic
Division name	Surgery
Address	3F Capital Building 4-261-1 Kishikicho, Oomiya-ku, Saitama-shi, Saitama, Japan 330-0843
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	自治医大さいたま医療センター，埼玉県立がんセンター，さいたま赤十字病院，赤心堂病院，三井病院，春日部市立病院，埼玉社会保険病院，川口市立医療センター

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 03 Month 16 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patient satisfaction at day 14 and day 28 Physician satisfaction at day 28 Pain degree at day 14 and day 28 4-level evaluation of Nausea, Vommiting, constipation, daytime drowsiness at day 14 and day 28

Management information
Registered date	2012 Year 04 Month 24 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009229