UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018451
Receipt No. R000021367
Scientific Title A study on the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Date of disclosure of the study information 2015/08/24
Last modified on 2019/07/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000021367

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.