A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Phase 2
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000032845
- Lead Sponsor
- PO corporation Digestive Disorder Support Organization (DDSO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with another malignant neoplasm 2) Patients who received preoperative chemo- or radiotherapy 3) Patients with preoperative malnutrition (alb less than 3.0g per dl) 4) Patients who were administrated Kanpo 5) Patients with allergy of ELENTAL 6) Patients with history of Kanpo allergy 7) Patients with severe psychiatric disorder 8) Patients who was considered ineligible by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change rate of mascle mass 6 months after intervention
- Secondary Outcome Measures
Name Time Method change rate of body weight and fat mass 6 months after intervention nutrition index compliance of adjuvant chemotherapy drug safty