UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027881 |
|---|---|
| Receipt number | R000031936 |
| Scientific Title | Development of supportive management to prevent docetaxel-induced peripheral neuropathy with compression therapy in patients with breast cancer. |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2023/07/14 09:45:03 |
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Basic information
Public title
Development of supportive management to prevent docetaxel-induced peripheral neuropathy with compression therapy in patients with breast cancer.
Acronym
Development of supportive management to prevent docetaxel-induced peripheral neuropathy with compression therapy.
Scientific Title
Development of supportive management to prevent docetaxel-induced peripheral neuropathy with compression therapy in patients with breast cancer.
Scientific Title:Acronym
Development of supportive management to prevent docetaxel-induced peripheral neuropathy with compression therapy.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of compression therapy in preventing docetaxel-induced peripheral neuropathy in patients with breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of docetaxel-induced peripheral neuropathy with any grade 1 or higher.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
sleeve and stocking
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
The patients with breast cancer who will be administered with docetaxel (75mg/BSA) (with anti-HER2).
Key exclusion criteria
1. The patient with peripheral neuropathy with any cause.
2. The patients with previous medication with anti-cancer drug
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Eguchi |
| Middle name | |
| Last name | Susumu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
8528051
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7316
ymanouch@gk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kosho |
| Middle name | |
| Last name | Yamanouchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
8528051
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7316
Homepage URL
koshoy@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
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
Clinical research center, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
Tel
095-819-7726
rinshou7726@umin.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
| 2017 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Published
Result
URL related to results and publications
https://ousar.lib.okayama-u.ac.jp/files/public/6/64119/20221221145018452275/76_6_689.pdf
Number of participants that the trial has enrolled
84
Results
There were no differences in median age, percentage of treatment for preoperative and postoperative/metastatic or recurrent disease, or concomitant anti-HER2 therapy between the groups. Docetaxel was completed in all patients, median relative dose intensity (range) 100 (85.0-00%). There was no difference in the incidence of peripheral neuropathy by the end of 4 courses of docetaxel (control vs. compression group: 63.5 vs. 76.9%, P=0.31).
Results date posted
| 2023 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients scheduled to receive docetaxel (DTX) for breast cancer in the Department of Surgery and Surgical Oncology, Nagasaki University Hospital are included. As controls, patients who received DTX for breast cancer from 2012 to 2016 (without sleeves and stockings) will be compared historically for frequency and severity of peripheral neuropathy.
Inclusion Criteria.
Patients who meet all of the following criteria will be included.
(1) Age: Patients who are at least 20 years old and less than 80 years old at the time of consent.
(2) Gender: Female
(3) Inpatient/outpatient: Both inpatients and outpatients are eligible to participate.
(4) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
(5) Pathology: Patients who plan to use DTX (75 mg/body surface area) alone or in combination with trastuzumab or pertuzumab as initial chemotherapy for metastatic or recurrent breast cancer or as preoperative or postoperative adjuvant therapy.
Participant flow
The investigators will give the research subjects a written explanation of consent that has been approved by the administrator of the institution, provide written and oral explanations, give them the opportunity to ask questions and sufficient time to decide whether or not to consent, and obtain their free and voluntary consent in writing after confirming that they understand the content of this research.
Adverse events
Two patients (7.7%) experienced adverse events due to the compression therapy; in both cases the adverse event was itching.
Outcome measures
Primary Endpoints
Incidence of CIPN grade 1 or higher CTCAE by the end of 4 DTX courses
Secondary endpoints
Grade of CIPN (CTCAE)
Incidence of CIPN at each course
Completion rate and safety of compression therapy with sleeve/stocking application
Changes in fingernails and skin of hands and feet
DTX reduction, postponement, and completion rate
Safety endpoints
Incidence, rate, and nature of adverse effects due to sleeve stocking applicatio
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031936
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