UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005829 |
|---|---|
| Receipt number | R000006878 |
| Scientific Title | Efficacy of pregabalin on the chemotherapy-induced neurotoxicity in patients with lung cancer |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2022/08/22 15:59:34 |
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Basic information
Public title
Efficacy of pregabalin on the chemotherapy-induced neurotoxicity in patients with lung cancer
Acronym
Efficacy of pregabalin on the chemotherapy-induced neurotoxicity in patients with lung cancer
Scientific Title
Efficacy of pregabalin on the chemotherapy-induced neurotoxicity in patients with lung cancer
Scientific Title:Acronym
Efficacy of pregabalin on the chemotherapy-induced neurotoxicity in patients with lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the efficacy of pregabalin on the chemotherapy-induced neurotoxicity in stage IIIB or IV patients with recurrent or advanced non-small cell lung cancer who are administered carboplatin and paclitaxel in the presence or absence of bevacizumab as 1st line chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in VAS scale in neurotoxicity including pain and paresthesia before and 14 days after pregabalin administration.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.stage IIIB or IV patients with recurrent or advanced non-small cell lung cancer who are administered carboplatin and paclitaxel in the presence or absence of bevacizumab as 1st line chemotherapy.
2.Neurotoxity is occured within a week after chemotherapy, VAS scale in neurotoxicity including pain and paresthesia>or=40mm.The neurotoxity is screened for questionnaire which is used in Japanese patients with chronic pain.
3.Age>or=20 years
4.Patients who agreed to participate in the study, and signed informed consent form
Key exclusion criteria
1.Patients with renal dysfunction,Ccr<or =30ml/min
2.The patients taking the following drugs recommended by IASP
Antidepressant/SSRI/SNRI/Antiepileptic agent/Opioid
3.Patients having the intracranial lesion with clinical symptoms
4.Patients with neuropathic pain by direct invasion of a tumor
5.Patient having the peripheral neuropathy caused by the etiology other than chemotherapy,VAS prior to the start of chemotherapy>or=30mm
6.Patients with past history of hypersensitivity to any of the ingredients in pregabalin
7.Patients with impaired consciousness
8.Patients with cardiac dysfunction
9.Other patients considered to be ineligible by the investigator
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takahashi |
Organization
Juntendo University School of Medicine
Division name
Pulmonary Critical Care Medicine
Zip code
Address
Bunkyo-ku hongou 2-1-1,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Koyama |
Organization
Juntendo University School of Medicine
Division name
Pulmonary Critical Care Medicine
Zip code
Address
TEL
Homepage URL
rkoyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Pulmonary Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Pulmonary Critical Care Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assess the change in VAS scale in neurotoxicity including pain and paresthesia before and 14 days after pregabalin administration.
Management information
Registered date
| 2011 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
