UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038108 |
|---|---|
| Receipt number | R000043437 |
| Scientific Title | Randomized controlled trial on the effectiveness of acupuncture for peripheral neuropathy by taxane anticancer drug treatment (multicenter collaborative research) |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2024/09/29 15:11:03 |
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Basic information
Public title
Randomized controlled trial on the effectiveness of acupuncture for peripheral neuropathy by taxane anticancer drug treatment (multicenter collaborative research)
Acronym
AcuNEXT
Scientific Title
Randomized controlled trial on the effectiveness of acupuncture for peripheral neuropathy by taxane anticancer drug treatment (multicenter collaborative research)
Scientific Title:Acronym
AcuNEXT
Region
| Japan |
Condition
Condition
Peripheral neuropathy caused by anticancer drugs
Classification by specialty
| Gastroenterology | Pneumology | Gastrointestinal surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of acupuncture in patients with peripheral neuropathy caused by taxane anticancer drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of numbness in the foot due to Visual Analogue Scale (VAS) [After 12 weeks]
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture
Interventions/Control_2
circular skin needle
Interventions/Control_3
no treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Within 3 years after completion of taxanes as preoperative or postoperative adjuvant chemotherapy for cancer.
2) Common Terminology Criteria for Adverse Events (CTCAE-JCOG v5.0) Grade 2 or higher symptoms of peripheral neuropathy (peripheral motor neuropathy, peripheral sensation) Neuropathy or neuralgia).
3) Outpatient visits are possible during the treatment and observation period.
4) After receiving sufficient explanations for participation in this research, with full understanding, document consent was obtained by the person's free will.
5) The age at the time of consent is between 20 and 80 years old.
Key exclusion criteria
1) Peripheral neuropathy falls under any of the following.
Neurologic symptoms that may be caused by sciatica or radiculopathy
Neurologic symptoms thought to be caused by peripheral nerve strangulation such as tarsal tunnel syndrome
Extremity sensory abnormalities that may be caused by cerebrovascular disorders
Peripheral peripheral circulatory disturbance based on obstructive arteriosclerosis or Raynaud's disease
Diabetic neuropathy
Numbness worsens after bathing.
2) It is difficult to receive acupuncture due to metal allergy.
3) Major organ functions such as liver function, kidney function, pulmonary function, and hemostatic function are severely impaired
4) A woman who is or may be pregnant.
5) Concomitant with psychosis or symptom, it is difficult to understand clinical trials.
6) In addition, the doctor responsible for research (sharing) determined that it was inappropriate.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | OHNO |
Organization
Shimane University Hospital
Division name
Clinical Research Center
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2259
ohno55@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | TOUMA |
Organization
Shimane University Hospital
Division name
Clinical Research Center
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2259
Homepage URL
hari@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Shimane University Hospital Foundation
for the Promotion of Advanced Medical Care
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Institutional Committee on Ethics
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
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
東京大学医学部附属病院（東京都）
埼玉医科大学病院（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 26 | 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
| 2019 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043437
