UMIN-CTR Clinical Trial

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
Email	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
Email	hishiba.thsr@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048898