UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021088 |
|---|---|
| Receipt number | R000024325 |
| Scientific Title | Effect of japanese traditional medicine, TJ-108, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2017/08/22 10:51:43 |
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Basic information
Public title
Effect of japanese traditional medicine, TJ-108, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Acronym
Effect of TJ-108 on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Scientific Title
Effect of japanese traditional medicine, TJ-108, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Scientific Title:Acronym
Effect of TJ-108 on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Region
| Japan |
Condition
Condition
non-small lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors influencing the QOL of TJ-108 in patients with lung cancer undergoing outpatient chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the quality of life (QOL)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To investigate the factors influencing the QOL for these patients, we answered using a QOL questionaire, "The QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs"(QOL-ACD) to patients with non-small cell lung cancer.
"Ninjin-Youei-Tou" is administered 2.5g 3 times after meal durung 4 weeks. Before administraion and after 4 weeks treatment of "Ninjin-Youei-Tou", QOL-ACD are conducted to evaluate QOL.
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
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with non-small lung cancer undergoing outpatient chemotherapy of PS 0-1
Key exclusion criteria
Poor status of PS, over 2.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Oncology Medicine
Zip code
Address
2-1 Imaizumihokubumachi, Toyama City
TEL
076-422-1112
ishiura@tch.toyama.toyama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Oncology Medicine
Zip code
Address
2-1 Imaizumihokubumachi, Toyama City
TEL
076-422-1112
Homepage URL
ishiura@tch.toyama.toyama.jp
Sponsor or person
Institute
Oncology Medicine of Toyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Toyama City
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
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No significant effect was observed.
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
| 2016 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | 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=R000024325
