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 |
A study on the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
A study on the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
Japan |
Elderly gastric cancer patients who are scheduled for gastrectomy
Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
1)Appetite(VAS:Visual Analog Scale)
2)CONUT(Controlling Nutritional Status) score
3)Skeletal muscle mass
evaluated at 3 and 6 month after operation
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
Central registration
2
Treatment
Medicine |
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.
No treatment
65 | years-old | <= |
Not applicable |
Male and Female
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
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
60
1st name | |
Middle name | |
Last name | Keisuke Koeda |
Iwate Medical University, School of
Medicine
Department of Surgery
19-1, Uchimaru, Morioka, Iwate, Japan
019-651-5111
keikoeda@iwate-med.ac.jp
1st name | |
Middle name | |
Last name | Keisuke Koeda |
Iwate Medical University, School of Medicine
Department of Surgery
19-1, Uchimaru, Morioka, Iwate
019-651-5111
keikoeda@iwate-med.ac.jp
Department of Surgery, Iwate Medical University, School of Medicine
TSUMURA & CO.
Profit organization
Japan
NO
岩手医科大学附属病院(岩手県)
2015 | Year | 08 | Month | 24 | Day |
Unpublished
Completed
2015 | Year | 06 | Month | 29 | Day |
2015 | Year | 07 | Month | 03 | Day |
2015 | Year | 08 | Month | 24 | Day |
2017 | Year | 07 | Month | 31 | Day |
2015 | Year | 07 | Month | 28 | Day |
2019 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021367
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