UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042853 |
|---|---|
| Receipt number | R000048898 |
| Scientific Title | A randomized, open-label, parallel-group study of the efficacy of oral Ninjin'yoeito in improving fatigability and nutritional status in the perioperative period of primary lung cancer |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/04 10:58:16 |
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Basic information
Public title
Efficacy of oral Ninjin'yoeito for improvement of fatigability and nutritional status in the perioperative period of primary lung cancer
Acronym
Efficacy of oral Ninjin'yoeito in the perioperative period of primary lung cancer
Scientific Title
A randomized, open-label, parallel-group study of the efficacy of oral Ninjin'yoeito in improving fatigability and nutritional status in the perioperative period of primary lung cancer
Scientific Title:Acronym
Efficacy of oral Ninjin'yoeito for improvement of fatigability and nutritional status in the perioperative period of primary lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A prospective study will be conducted to evaluate the efficacy of Ninjin'yoeito by administering Ninjin'yoeito in the perioperative period to patients aged 65 years or older who are scheduled for surgery for primary lung cancer, and comparing them with patients in the group that does not receive Ninjin'yoeito to subjectively and objectively evaluate the patients' nutritional status, fatigability, and recovery status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chalder Fatigue Scale before administration of Ninjin'yoeito, a month after surgery, and 6 months after surgery.
Key secondary outcomes
Cancer Fatigue Scale, Kihon Checklist (KCL), and Controlling nutrition status (COUNT)and Prognostic nutritional index(PNI) before administration of Ninjin'yoeito, a month after surgery, and 6 months after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Three packets of 3.0g (9.0g)of Ninjin'yoeito per day should be taken before or between meals. The dosage should be taken from 2 weeks before to 24 weeks after surgery for primary lung cancer.
Interventions/Control_2
Patients do not take Ninjin'yoeito.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 65 years or older who will undergo anatomical lung resection and systematic lymph node dissection for primary lung cancer at our department.
2. Patients who have given written consent for this study.
3. Patients with primary lung cancer in stages 0, I, II and III.
Key exclusion criteria
1. The patient does not give consent to participate in the study.
2.The patient has a history of allergy to Ninjin'yoeito or its components.
3. The patient has severe anorexia, nausea, or vomiting, which is a cautious administration of the study drug.
4. The patient with severe hepatic or renal dysfunction.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Ishibashi |
Organization
Tokyo Medical and Dental University
Division name
Department of Thoracic Surgery, Graduate school of Medical and Dental Sciences
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4072
hishiba.thsr@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Ishibashi |
Organization
Tokyo Medical and Dental University
Division name
Department of Thoracic Surgery, Graduate school of Medical and Dental Sciences
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4072
Homepage URL
hishiba.thsr@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Ethics Review Committee, Faculty of Medicine, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2021 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 12 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048898
