Skip to content

A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy

A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy - A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032845
Enrollment
100
Registered
2018-09-01
Start date
2018-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Dayly administration of ELENTAL (300kcal) for 6 months from the start of adjuvant chemotherapy Dayly administration of ELENTAL (300kcal) and Rikkunshito 7.5g for 6 months from the start of adjuvant ch

Sponsors

NPO corporation Digestive Disorder Support Organization (DDSO)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who received R0 resection by distal or proximal gastrectomy 2) Patients who will receive adjuvant chemotherapy 3) Patients with apptite loss or malnutrition on POD 7 4) Patients without severe complications (heart disease, pulmonary fibrosis, intestinal pneumonia, bleeding tendency) 5) Patients who will be alive for more than 6 months 6) Patients who can take oral nutrition 7) Patients whose age is more than 20 8) Patients who approved written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
change rate of mascle mass 6 months after intervention

Secondary

MeasureTime frame
change rate of body weight and fat mass 6 months after intervention nutrition index compliance of adjuvant chemotherapy drug safty

Countries

Japan

Contacts

Public ContactSachio Fushida

Kanazawa University Hospital Gastroenterological Surgery

fushida@staff.kanazawa-u.ac.jp076-265-2362

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026