Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer
Phase 2
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000032256
- Lead Sponsor
- Okayama University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1.diagnosis of other organ cancer 2.contraindications to Rehadays (allergy to milk or coffee) 3.active infection or inflamation 4.uncontrolled diabetes 5.pregnancy or intention for pregnancy 6.Immunodeficiency 7.clinically relevant cardiac or pulmonary disease 8.history of clinically relevant mental disorder or central nervous system disorder 9.Unsuitable patients for enrollment judged by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight loss rate at 4-6 weeks after total gastrectomy
- Secondary Outcome Measures
Name Time Method 1.compliance with oral nutritional supplement 2.muscle mass loss rate 3.body composition change 4.nutrition related blood parameters (serum total protein, serum albumin, total cholesterol, total lymphocyte number, c-reactive protein, multifunctionality and exhaustion of lymphocyte) 5.postoperative complication 6.quolity of life 7.postoperative bodyweight and body composition changes at 3m, 6m and 12m. 8.compliance with adjuvant chemotherapy