UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043729 |
|---|---|
| Receipt number | R000049924 |
| Scientific Title | Multicenter observational study of chemotherapy-induced peripheral neuropathy prevention |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/10/01 16:03:17 |
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Basic information
Public title
Multicenter observational study of chemotherapy-induced peripheral neuropathy prevention
Acronym
Multicenter Observational Study of CIPN prevention
Scientific Title
Multicenter observational study of chemotherapy-induced peripheral neuropathy prevention
Scientific Title:Acronym
Multicenter Observational Study of CIPN prevention
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the reduction of chemotherapy-induced neuropathy by prevention methods
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Incidence of CIPN:Score of hands in Patient Neurotoxicity Questionnaire (PNQ)
2)Incidence of CIPN in hands:CTCAE grade over 2
3)Incidence of CIPN:Score of feet in PNQ
4)Incidence of CIPN in feet:CTCAE grade over 2
Key secondary outcomes
1)Number of cycles to CIPN PNQ Score D
2)Number of cycles to CIPN CTCAE grade over 2
3)Incidence of CIPN in hands and feet
4) Incidence of CIPN in hands and feet till the date of primary endpoint by CTCAE
5) Time to CIPN PNQ score over D in hands
6) Incidence and Time to CIPN of CTCAE Grade over 2 in hands
7) Time to CIPN PNQ score over D in feet
8) Incidence and Time to CIPN of CTCAE Grade over 2 in feet
9) Finger dexterity with Grooved pegboard test
10) Tactile sense by Semmes-Weinstein monofilament Test
11)Incidence and Time to Skin and subcutaneous tissue disorders
12) Temperature of hands and feet before and after compression or cryotherapy
13) Incidence of cases dropping out
14) Pressure of ECGS
15) Time to prescription for CIPN
16) Fall frequency
17) PNQ by electronic Patient Reported Outcome
18) Diary by electronic Patient Reported Outcome
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
| 20 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Female
Key inclusion criteria
1)Pathological Diagnosis of invasive ductal carcinoma of Breast cancer
2)Primary, advanced or recurrent cancer patients planning to receive more than 12cycles of weekly Paclitaxel therapy
(weekly Paclitaxel with Trastuzumab and Pertuzumab included), or PTX+Bevacizmab more than 3cycle, or nab-PTX more than 4cycle
3)ECOG Scale 0 or 1
4)Non ECG abnormality
5)No obvious interstitial pneumonia or pulmonary fibrosis on chest X-ray or CT
Key exclusion criteria
1)Patients who have CTCAE more than grade1 neuropathy and/or skin disorders
2)Patients taking pregabalin, etc. to control neuropathic pain
3)active double cancer (except lesions corresponding to carcinoma in situ or intramucosal cancer that are judged to be cured by local treatment are not included in the double cancer).
4)active brain metastasis
5)Diabetes mellitus with peripheral neuropathy, infectious diseases (on limbs) that are judged to interfere with prevention, and other serious complications are observed.
6)History of severe drug hypersensitivity in therapeutically important drugs in this study
7)History of serious mental illness or under treatment
8)HBsAg positive and untreated
9)History of serious heart or respiratory illness
10)May be pregnant or pregnant
11)In addition, when the principal investigator or the research coordinator determines that the subject is inappropriate (specific example: signs of peripheral circulatory insufficiency such as Raynaud's phenomenon)
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Kawaguchi-Sakita |
Organization
Kyoto University Hospital
Division name
Department of Real World Data R&D,Graduate School of Medicine,Kyoto University
Zip code
606-8507
Address
54 Shogoin Kawara-cho Sakyo-ku, Kyoto
TEL
+81-75-751-3660
nobuko75@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Kitamura |
Organization
Kyoto Breast Cancer Research Network (KBCRN)
Division name
-
Zip code
604-0883
Address
25 Mori Building,610 Kusunoki-cyo,ainomachidori takeyamachi sagaru,Nakagyo-ku,Kyoto
TEL
075-585-7861
Homepage URL
info@kyoto-breast-cancer.org
Sponsor or person
Institute
Kyoto Breast Cancer Research Network (KBCRN)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society of Clinical Oncology
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
+81-75-753-4680
ethcom@kuhp.kyoto-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
大阪赤十字病院（大阪府）
関西医科大学附属病院（大阪府）
京都大学医学部附属病院（京都府）
神戸市立医療センター中央病院（兵庫県）
神鋼記念病院（兵庫県）
兵庫県立尼崎総合医療センター（兵庫県）
田附興風会医学研究所北野病院（大阪府）
天理よろづ相談所病院（奈良県）
東京都立駒込病院（東京都）
日本赤十字社和歌山医療センター（和歌山県）
博愛会相良病院（鹿児島県）
埼玉医科大学国際医療センター（埼玉県）
京都市立病院（京都府）
京都医療センター（京都府）
大和高田市立病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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
238
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the reduction of chemotherapy-induced neuropathy by prevention method( compression therapy etc)
Management information
Registered date
| 2021 | Year | 03 | Month | 24 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049924
