UMIN-CTR Clinical Trial

Basic information
Public title	A study on the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Acronym	Efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Scientific Title	A study on the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Scientific Title:Acronym	Efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Region	Japan

Condition
Condition	Elderly gastric cancer patients who are scheduled for gastrectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients by using their appetite score and nutritional status as indexes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1)Appetite(VAS:Visual Analog Scale) 2)CONUT(Controlling Nutritional Status) score 3)Skeletal muscle mass evaluated at 3 and 6 month after operation
Key secondary outcomes	1)Postoperative complications 2)PNI(Prognostic Nutritional Index) 3)Changes in body weight 4)Frailty(Muscle mass, Muscle strength, Physical ability) 5)QOL(Quality of Life)evaluation: SF-12 standard version 6)IADL(Instrumental Activities of Daily Living) evaluation:TMIG Index of Competence 7)Preoperative depression score: K6/K10 Japanese version 8)Postoperative hospital stay 9)Feasibility 10)Clinical examination:Alb, Lym, T-Cho, T-Bil, ALT, AST, GTP, CRP, BUN, Cr, Na, K, Cl 11)Adverse events 12)Side effects

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of Hochuekkito (2.5g t.i.d before or between meals) for 2 weeks until the day before surgery and from the second day up to 6 months after surgery.
Interventions/Control_2	No treatment
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 complain of loss of appetite 2)Patients scheduled to enforce a total gastrectomy or distal gastrectomy 3)Preoperative staging:IA-IIIA 4)Operative procedure*Open surgery, laparoscopic surgery, laparoscopic assisted surgery 5)Reconstruction: Roux-en-Y, Billroth-I 6)PS(ECOG Performance Status Scale):0-1 7)Age:over65 8)Gender:No object 9)Out patient or inpatient:Out patient 10)Patient oral administration is possible 11)Agreement to sign an informed consent
Key exclusion criteria	1)Patients who are scheduled for radiation therapy in the preoperative orintraoperative 2)Patients with a history of radiation therapy to the abdomen 3)Patients who are scheduled to management by artificial respiration after surgery 4)Patients with either a history has been complicated by inflammatory bowel diseases such as ulcerative colitis or Crohn's disease 5)Patients who underwent emergency surgery 6)Patients with double cancer 7)Patients with peritoneal metastasis (Peritoneal Lavage Cytology or Pathological diagnosis) 8)Patients who are scheduled to bowel resection 9)Patients with major organs (bone marrow, heart, liver, kidney, lungs, etc.) the function of the not retained 10)Patients with a history of bowel resection 11)Patients with a history of abdominal surgery and peritonitis (Except for patients with appendectomy) 12)Patients with diabetes to have performed insulin therapy 13)Patients receiving steroids 14)Patients taking the Kampo Products within 4 weeks prior to study drug administration 15)Patients were considered to be inappropriate by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Koeda
Organization	Iwate Medical University, School of Medicine
Division name	Department of Surgery
Zip code
Address	19-1, Uchimaru, Morioka, Iwate, Japan
TEL	019-651-5111
Email	keikoeda@iwate-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Keisuke Koeda
Organization	Iwate Medical University, School of Medicine
Division name	Department of Surgery
Zip code
Address	19-1, Uchimaru, Morioka, Iwate
TEL	019-651-5111
Homepage URL
Email	keikoeda@iwate-med.ac.jp

Sponsor
Institute	Department of Surgery, Iwate Medical University, School of Medicine
Institute
Department

Funding Source
Organization	TSUMURA & CO.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	岩手医科大学附属病院（岩手県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 24 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	Completed
Date of protocol fixation	2015 Year 06 Month 29 Day
Date of IRB	2015 Year 07 Month 03 Day
Anticipated trial start date	2015 Year 08 Month 24 Day
Last follow-up date	2017 Year 07 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	2015 Year 07 Month 28 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021367