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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030536
Receipt No. R000034856
Scientific Title A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Date of disclosure of the study information 2017/12/24
Last modified on 2019/06/25

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Basic information
Public title A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Acronym Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
Scientific Title A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Scientific Title:Acronym Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
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 To evaluate of the prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nanoparticle albumin-bound(nab)-paclitaxel-induced peripheral neuropathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The incidence of grade 2 or higher nab-paclitaxel-induced peripheral neuropathy.
Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy.
Key secondary outcomes 1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control.
2.Withdrawal of intervention procedures
3.Adverse events of interventional procedures
4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.)
5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 During chemotherapy, wear a frozen glove on one hand and a surgical glove on the other hand continuously, as for frozen glove from 15 minutes before the start of administration of nab-PTX until 15 minutes after the end of the infusion (60 minutes), as for surgical glove from 30 minutes before the start of administration of nab-PTX until 30 minutes after the end of the infusion (90 minutes).
For hands wearing frozen gloves or surgical gloves, "dominant hand" is assigned randomly as the allocation factor.
Interventions/Control_2 Using the thermography, the fingertip
temperature of both hands before and after wearing the glove was measured.
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

Not applicable
Gender Female
Key inclusion criteria Women with pathologically proven primary or recurrent breast cancer, 20 years of age and older
No peripheral sensory/motor neuropathy or Grade 1 peripheral sensory/motor neuropathy without left/right differences
Patients who can answer Japanese questionnaire without assistance
With written informed consent
Key exclusion criteria With allergy for material of frozen globe and surgical glove
Patients with neuropathic pain due to diseases such as diabetes and herpes zoster

Target sample size 34

Research contact person
Name of lead principal investigator
1st name Yuko Kanbayashi
Middle name
Last name Kanbayashi
Organization Kyoto Prefectural University of Medicine
Division name Outpatient Oncology Unit
Zip code 602-8566
Address Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5111
Email ykokanba@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Kanbayashi
Organization Kyoto Prefectural University of Medicine
Division name Outpatient Oncology Unit
Zip code 602-8566
Address Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5111
Homepage URL
Email ykokanba@koto.kpu-m.ac.jp

Sponsor
Institute Department of Outpatient Oncology Unit, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine
Address Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel 075-251-5337
Email rinri@koto.kpu-m.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 京都府立医科大学附属病院(京都府)
Kyoto Prefectural University of Medicine Hospital(Kyoto)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 24 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
2017 Year 07 Month 11 Day
Date of IRB
2017 Year 07 Month 25 Day
Anticipated trial start date
2017 Year 08 Month 29 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 23 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034856

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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