UMIN-ICDS Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

nakamura.yoshimi.f7@f.gifu-u.ac.jp

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

Email

nakamura.yoshimi.f7@f.gifu-u.ac.jp

Institute

others

Institute

Department

Personal name

Organization

others

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gifu University Hospital

Address

1-1 Yanagido, Gifu City, Gifu Prefecture

Tel

0582306404

Email

nakamura.yoshimi.f7@f.gifu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000059376