UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018451
Receipt number 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 10:01:34

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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 or person

Institute

Department of Surgery, Iwate Medical University, School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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