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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016814 |
Receipt No. | R000019486 |
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 |
Date of disclosure of the study information | 2015/03/16 |
Last modified on | 2017/03/31 |
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 |
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Condition | |||||||
Condition | Neuropathic pain induced by chemotherapy for breast and gynecological cancer | ||||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
neurosaitoh@mbk.nifty.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |