UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015216 |
|---|---|
| Receipt number | R000016418 |
| Scientific Title | Effect of treatment with compression gloves and compression stockings to prevent paclitaxel-induced peripheral. neuropathy |
| Date of disclosure of the study information | 2014/09/21 |
| Last modified on | 2016/09/05 11:10:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of treatment with compression gloves and compression stockings to prevent paclitaxel-induced peripheral. neuropathy
Acronym
gloves and stockings to prevent paclitaxel-induced peripheral neuropathy
Scientific Title
Effect of treatment with compression gloves and compression stockings to prevent paclitaxel-induced peripheral. neuropathy
Scientific Title:Acronym
gloves and stockings to prevent paclitaxel-induced peripheral neuropathy
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By wearing compression gloves and compression stockings at start of chemotherapy, we analyze period to occurrence, frequency, and extent of peripheral neuropathy. We also evaluate relationship among peripheral neuropathy and effect and dose intensity of chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of peripheral neuropathy in the third cycle before starting
Key secondary outcomes
1) period to development of neurotoxicity (grade 2 or more)
2)proportion of cases who experience contra-lateral neuropathy previous to intervention side.
3) grade of neuropathy
4)relationship among proportion of neuropathy and proportion of completion and effect of chemotherapy.
5) safety of compression gloves and compression stockings.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
May26,2014-May31,2015
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) planning to treat with paclitaxel and nob-paclitaxel.
2) 20 years old or more
3) no neuropahty before enrollment
4) controlled diabetes mellitus (DM) or no DM
5) no significant skin disorder of extremities
Key exclusion criteria
1) any grade of neurotoxicity
2) no ability to express toxicity
3) significant skin disorder of extremites
4) symptomatic brain metastasis
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
respiratory medicine
Zip code
Address
47-1 Nodayama Shiote aza Medeshima Natorishi Miyagi
TEL
022-384-3151
maemondo-ma693@niyagi-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
respiratory medicine
Zip code
Address
47-1 Nodayama Shiote aza Medeshima Natorishi Miyagi
TEL
022-384-3151
Homepage URL
maemondo-ma693@niyagi-pho.jp
Sponsor or person
Institute
Miyagi Cancer center
Institute
Department
Personal name
Funding Source
Organization
Miyagi Cancer Center
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
Address
Tel
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
| 2014 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 21 | Day |
Last modified on
| 2016 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016418
