stage I-III stomach cancer
Conditions
Interventions
Control group
PSK before surgery group 3 times per day (3g) 2 weeks p.o. daily
Sponsors
JIKEI UNIVERSITY SCHOOL OF MEDICINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Stage I-III stomach cancer before surgery 2.60<=age<80 when get consent 3.Patient be scheduled surgery 4.Patient can take PSK 2 weeks before surgery 5.Patient didn't treated cancer therapy (radiation, chemotherapy, immunotherapy) 6.Patient has not double cancer 7.Patient has not severe disorder with renal function, hepatic function, bone-marrow function and maintain following function of main organ (laboratory data is before surgery and last data within 2 weeks before surgery) Digestive tract function: patient has not diarrhea White blood cell count: >=4000/mm3 and <12,000/mm3 Neutrophil count: >=2000/mm3 Thrombocyte count: >=100,000/mm3 Hemoglobin content: >=9.0g/dL Serum GOT and GPT: less than 100IU/L Serum total bilirubin: less than 1.5mg/dL Serum creatinine: less than 1.5mg/dL 8.Performance status is 0-2 (ECOG) 9.Patient has not severe complication (myelosuppression, diarrhea, infection and so on) 10.Patient can tolerate this trial and get consent in writing
Exclusion criteria
Exclusion criteria: 1.Fresh bleed from gastrointestinal tract 2.Body cavity fluid accumulation 3.Infection, intestinal tract paralysis, intestinal obstruction 4.Pregnant patient 5.Insulin treatment or uncontrolled diabate patient 6.Patient with a history of ischemic cardiac disease 7.Insanity, psychological symptom patient 8.Stable dose of steroid patient 9.Patient with a history of severe drug allergies 10.Advancing infection patient 11.Organ failure patient And patient be disqualified as target by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunosuppressive parameter(IL-6, IL-10, TGF-beta) Each parameter is measured to the following timing. Before PSK administration before surgery After PSK administration before surgery Within 3 days after surgery 3 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Surgical Site Infections Surgical stress marker (MCP-1; Monocyte Chemoattractant Protein-1) Serum albumin Perioperative changes of CRP Withdrawal rate of clinical path Period of hospitalization | — |
Countries
Japan
Outcome results
None listed