UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020852 |
|---|---|
| Receipt number | R000024065 |
| Scientific Title | An observational study of nab-paclitaxel-induced peripheral neuropathy |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2023/02/07 14:04:42 |
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Basic information
Public title
An observational study of nab-paclitaxel-induced peripheral neuropathy
Acronym
An observational study of nab-paclitaxel-induced peripheral neuropathy
Scientific Title
An observational study of nab-paclitaxel-induced peripheral neuropathy
Scientific Title:Acronym
An observational study of 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 assess the long term outcome of nab-paclitaxe-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 long-term outcome of nab-paclitaxel-induced peripheral neuropathy
Key secondary outcomes
(1)The validity of neuropathic pain screening tool
(2) To evaluate the effect of frozen globes and elastic stockings for nab-paclitaxel-induced peripheral neuropathy
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
| Not applicable |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Patients are histologically proven breast cancer
(2) Scheduled to receive nab-paclitaxel as primary systemic therapy for breast cancer
(3)Sensory neuropathy(grade)0-1
(4)Patients are previously treated with a taxane-containing regimen
Key exclusion criteria
(1)Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuhide |
| Middle name | |
| Last name | Yoshidome |
Organization
Osaka Police Hospital
Division name
Department of Breast Surgery
Zip code
5430035
Address
Tennouji ward
TEL
0667716051
oph@live.jp
Public contact
Name of contact person
| 1st name | Katsuhide |
| Middle name | |
| Last name | Yoshidome |
Organization
Osaka Police Hospital
Division name
Department of Breast Surgery
Zip code
5430035
Address
Tennouji ward
TEL
0667716051
Homepage URL
oph@live.jp
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
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
Osaka Police Hospital
Address
10-31 Kitayama Ten-noji Osaka, Japan
Tel
06-6771-6051
shomu@oph.gr.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
大阪警察病院（大阪府）
りょうクリニック（大阪府）
八尾市立病院（大阪府）
大阪府立急性期・総合医療センター（大阪府）
大阪労災病院（大阪府）
JCHO大阪病院（大阪府）
日生病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000024065
Publication of results
Partially published
Result
URL related to results and publications
https://www.abstracts2view.com/sabcs17/view.php?nu=SABCS17L_311
Number of participants that the trial has enrolled
105
Results
Patient-reported nPIPN was significantly getting worse without frozen gloves during chemotherapy, however be largely reversible within 1 year of PST or adjuvant treatment. The J-Q findings support that nab-PTX treatment is tolerable.
Results date posted
| 2021 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between May 2013, and April 2016, 105 patients were enrolled from 7 hospitals.
Participant flow
In 73 patients (69.5%) nab-PTX was administered as primary and in 32 patients (30.5%) as adjuvant therapy. Forty three (41.0%) patients received nab-PTX as first line and 62 (59.0%) received after anthracycline contained regimen. Trastuzumab was administered as combination therapy with nab-PTX for Her2 positive patients. Both frozen gloves and stockings were used in 21 patients (20.0%) and frozen gloves only were used in 21 patients (20.0%) according to patient preference.
One hundred patients (95.2%) completed four courses, and overall relative dose intensity was 91.4%.
Adverse events
Dropout patients: one PD, two worsening of hepatic failure, one CIPN and one thrombocytopenia
Outcome measures
During chemotherapy, J-Q scores go elevated from day 1 to day 5 and gradually declined throughout the rest of the cycle. Without using frozen gloves, there was a significant increase according to courses (1st: 45.0 +/- 5.7, 2nd: 76.7 +/- 8.6, 3rd: 94.3 +/- 11.8, 4th: 95.4 +/- 11.8). Using frozen gloves, there was a significant increase from 1st course to 2nd, but no further increase was observed(1st: 37.4 +/- 8.1, 2nd: 61.9 +/- 12.4, 3rd: 62.9 +/- 10.4, 4th: 55.3 +/- 10.6). After six months and one year, the scores were significantly lower compared with the last day of the fourth cycle (4.28 +/- 0.50, 2.53 +/- 0.25, 2.85 +/- 0.39, respectively). CTC, grade 2 or more sensory disturbance was observed in 57.9% after four cycles but improved to 9.5% and 5.4% after six months and one year respectively.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Study design: observational study (cohort study)
Patinets: Patients included in the study were treated with nab-paclitaxel for breast cancer between Aug 2013 and Feb 2016
1. age
2. sex
3. treatment history (operation, radiation, chemotherapy other than nab-paclitaxel)
4. performance status
5. starting date and duration of nab-paclitaxel
6. treatment for prevention of adverse events
7. peripheral neuropathy survey during the treatment period and six and twelve months after the treatment.
8. reason for interruption
Management information
Registered date
| 2016 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024065
