UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052769 |
|---|---|
| Receipt number | R000059376 |
| Scientific Title | Chemotherapy-induced peripheral neuropathy using Pain Vision Observational Study to Investigate the Effectiveness of Objective Evaluation |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2023/11/11 23:56:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Chemotherapy-induced peripheral neuropathy using Pain Vision Observational Study to Investigate the Effectiveness of Objective Evaluation
Acronym
Chemotherapy-induced peripheral neuropathy using Pain Vision Observational Study to Investigate the Effectiveness of Objective Evaluation
Scientific Title
Chemotherapy-induced peripheral neuropathy using Pain Vision Observational Study to Investigate the Effectiveness of Objective Evaluation
Scientific Title:Acronym
Chemotherapy-induced peripheral neuropathy using Pain Vision Observational Study to Investigate the Effectiveness of Objective Evaluation
Region
| Japan |
Condition
Condition
Patients who developed peripheral neuropathy during chemotherapy treatment at our hospital and were evaluated as NCI-CTCEA Grade 2 by the pharmacist
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Measurement using a sensory pain quantitative analyzer (Nipro Pain Vision ) (number of pain degrees, lowest perceived current value, pain perceived current value), grade evaluation by medical professionals, and patient evaluation using VAS and questionnaire methods will be conducted and compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Main evaluation items]
Patient VAS and questionnaire method FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity), PNQ (Patient Neurotoxicity Questionnaire) and Pain vision (pain frequency, lowest perceived current value, pain perceived current value )
[Secondary evaluation items]
participation rate
Effectiveness of supportive care (duloxetine, gabapentinoids, opioids)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients 18 years of age or older who have been evaluated as Grade 2 or higher by the chemotherapy room pharmacist between the date of approval and December 31, 2028.
Patients who have given written consent to participate in this study
Key exclusion criteria
Patients being treated with implantable medical devices such as pacemakers and ICDs
Other patients who are judged to be inappropriate by the doctor's judgment
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Nakamura |
Organization
Gifu University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
058-230-6404
nakamura.yoshimi.f7@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshmi |
| Middle name | |
| Last name | Nakamura |
Organization
Gifu University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
0582306404
Homepage URL
nakamura.yoshimi.f7@f.gifu-u.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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
Gifu University Hospital
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
Tel
0582306404
nakamura.yoshimi.f7@f.gifu-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who developed peripheral neuropathy during chemotherapy treatment at our hospital and were evaluated as Grade 2 by the chemotherapy room pharmacist were targeted. After contacting the attending physician and obtaining written consent from the patient, measurements (pain frequency, lowest perceived current value, pain perceived current value) are performed using a sensory pain quantitative analyzer (Nipro Pain Vision ) owned by our department. Comparative studies will be conducted using grade evaluations by workers, patient VAS, and questionnaire methods.
If duloxetine, gabapentinoids, or opioids are used for CIPN, pain vision (pain frequency, lowest perceived current value, pain perceived current value), grade evaluation by medical professionals, and patient Evaluate using VAS and questionnaire methods.
Management information
Registered date
| 2023 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059376
