UMIN-CTR Clinical Trial

Basic information
Public title	A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Acronym	A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Scientific Title	A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Scientific Title:Acronym	A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	preventional efficacy of body composition decline (body weight, muscle mass, fat mass) nutrition index (Alb, TP, T-Chol, prealubmin, NLR) compliance of adjuvant chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	change rate of mascle mass 6 months after intervention
Key secondary outcomes	change rate of body weight and fat mass 6 months after intervention nutrition index compliance of adjuvant chemotherapy drug safty

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dayly administration of ELENTAL (300kcal) for 6 months from the start of adjuvant chemotherapy
Interventions/Control_2	Dayly administration of ELENTAL (300kcal) and Rikkunshito 7.5g for 6 months from the start of adjuvant chemotherapy
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) Patients who received R0 resection by distal or proximal gastrectomy 2) Patients who will receive adjuvant chemotherapy 3) Patients with apptite loss or malnutrition on POD 7 4) Patients without severe complications (heart disease, pulmonary fibrosis, intestinal pneumonia, bleeding tendency) 5) Patients who will be alive for more than 6 months 6) Patients who can take oral nutrition 7) Patients whose age is more than 20 8) Patients who approved written informed consent
Key exclusion criteria	1) Patients with another malignant neoplasm 2) Patients who received preoperative chemo- or radiotherapy 3) Patients with preoperative malnutrition (alb less than 3.0g per dl) 4) Patients who were administrated Kanpo 5) Patients with allergy of ELENTAL 6) Patients with history of Kanpo allergy 7) Patients with severe psychiatric disorder 8) Patients who was considered ineligible by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Sachio Middle name Last name Fushida
Organization	Kanazawa University Hospital
Division name	Gastroenterological Surgery
Zip code	920-8641
Address	13-1 Takara-machi, Kanazawa
TEL	076-265-2362
Email	fushida@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Sachio Middle name Last name Fushida
Organization	Kanazawa University Hospital
Division name	Gastroenterological Surgery
Zip code	920-8641
Address	13-1 Takara-machi, Kanazawa
TEL	076-265-2362
Homepage URL
Email	fushida@staff.kanazawa-u.ac.jp

Sponsor
Institute	NPO corporation Digestive Disorder Support Organization (DDSO)
Institute
Department

Funding Source
Organization	NPO corporation Digestive Disorder Support Organization (DDSO)
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	Innovative Clinical Research Center, Kanazawa University
Address	13-1 Takara-machi, Kanazawa
Tel	076-265-2000
Email	hpsangak@adm.kanazawa-u.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	2018 Year 09 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	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 10 Month 03 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 02 Day
Last modified on	2021 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037445