UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer
Acronym	rTMS for chemotherapy-induced neuropathic pain
Scientific Title	Efficacy of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer
Scientific Title:Acronym	rTMS for chemotherapy-induced neuropathic pain
Region	Japan

Condition
Condition	Neuropathic pain induced by chemotherapy for breast and gynecological cancer
Classification by specialty	Neurology Breast surgery Obsterics and gynecology Anesthesiology Neurosurgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain reduction in visual analogue scale
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Active stimulation (M1 hand)
Interventions/Control_2	Active stimulation (M1 hand, high stimulus intensity)
Interventions/Control_3	Active stimulation (M1 foot)
Interventions/Control_4	Sham stimulation
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	Patients with peripheral neuropathic pain induced by chemotheraphy for breast or gynecological cancer Patients with pain duration of 3 months or longer Patients with moderate or sevvere pain (VAS: 30mm or more) Patients with agreement with no change of ordinary drugs during trial Patients with an informed consent given
Key exclusion criteria	Patients suffering from cognitive impairments, aphasia, or a major psychiatric disease Patients with a desire for suicide Patients who cannot write the questionnaires Patients with an implanted metal in a head excluding a mouth Patients with a cardiac pacemaker, devices for deep brain stimulation, or an implanted medication pump Patients suffering from serious heart diseases Patients suffering from a major cerebral infarction or head a trauma Patients suffering from a brain tumor Patients with epilepsy episode history Pregnant patients
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Youichi Saitoh
Organization	Osaka University
Division name	Department of Neuromodulation and Neurosurgery
Zip code
Address	2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL	+81-6-6210-8435
Email	neurosaitoh@mbk.nifty.com

Public contact
Name of contact person	1st name Middle name Last name Koichi Hosomi
Organization	Osaka University
Division name	Department of Neuromodulation and Neurosurgery
Zip code
Address	2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL	+81-6-6210-8435
Homepage URL
Email	k-hosomi@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Department of Neuromodulation and Neurosurgery
Institute
Department

Funding Source
Organization	Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Osaka University Graduate School of Medicine, Department of Breast and Endcrine surgery, Department of Obstetrics and Gynecology
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 03 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 03 Month 09 Day
Date of IRB
Anticipated trial start date	2015 Year 03 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

Management information
Registered date	2015 Year 03 Month 16 Day
Last modified on	2017 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019486

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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