A study on the efficacy and safety of Hochuekkito for anorexia of elderly gastric cancer patients
- Conditions
- Elderly gastric cancer patients who are scheduled for gastrectomy
- Registration Number
- JPRN-UMIN000018451
- Lead Sponsor
- Department of Surgery, Iwate Medical University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Appetite(VAS:Visual Analog Scale) 2)CONUT(Controlling Nutritional Status) score 3)Skeletal muscle mass evaluated at 3 and 6 month after operation
- Secondary Outcome Measures
Name Time Method 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