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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043729
Receipt No. 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 2021/03/24

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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 Clinical Oncology
Zip code 606-8507
Address 54 Shogoin Kawara-cho Sakyo-ku, Kyoto
TEL +81-75-751-3660
Email 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 601-8001
Address 1-10 Higashikuzyou muromachi Minami-ku, Kyoto
TEL 075-585-7861
Homepage URL
Email info@kyoto-breast-cancer.org

Sponsor
Institute Kyoto Breast Cancer Research Network (KBCRN)
Institute
Department

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
Email 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)


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
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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2025 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
2021 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049924

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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