Gastric Cancer
Conditions
Interventions
Oral administration of Hangeshashinto 7.5g/day t.i.d. before meals or between meals.
Oral administration of placebo 7.5g/day t.i.d. before meals or between meals.
Sponsors
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Chemotherapy receiving. (2)Developed oral mucositis right before chemotherapy. (3)ECOG P.S. of 0, 1 or 2. (4)Age of at least 20 years at registration. (5)A life expectancy of more than 12 weeks. (6)Adequate function of vital organs, as evidenced by the following data within 7 days before registration: hematopoietic function white blood cell count >=2,500/mm3 and <= 12,000/mm3. neutrophil count >= 1.500/mm3. platelet count >= 100,000/mm3. liver function aspartate aminotransferase and alanine aminotransferase levels less than 2.5 times the institutional upper limit of normal.(with liver metastasis less than 5 times) total bilirubin level less than 1.5 times the institutional upper limit of normal. renal function serum creatinine level below the institutional upper limit of normal. (7)All patients provided written informed consent before initiation of study-related procedures.
Exclusion criteria
Exclusion criteria: (1)Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. (2)Patients who had used traditional Japanese medicines (Kampo) within 2 weeks before registration. (3)History of severe hypersensitivity (allergy) to any medicines. (4)Patients who had received antiphlogistic analgetic, opioid, or steroid. (5)Prior or current therapy for neuropathy or sensory dysfunction. (6)Other active malignancies. (7)Uncontrolled pleural effusion or ascites. (8)A systemic inflammatory condition or serious infection. (9)Brain metastasis. (10)Significant electrocardiographic abnormality. (11)Clinically problematic cardiac disease (congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, or myocardial infarction within the past 12 months). (12)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, etc.). (13)Gastrointestinal bleeding that requires medication or transfusion. (14)Diarrhea (watery) or diarrhea that interferes with daily activities for patients with a stoma. (15)Myelosuppresion. (16)Ileus or bowel obstruction. (17)Central nervous system disorders. (18)Dementia. (19)Serious psychological disease. (20)Uncontrolled diabetes mellitus with or without diabetic neuropathy. (21)Serious constipation. (22)Pregnant or lactating women. (23)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CTCAE grade 2 <= oral mucositis. | — |
Countries
Japan
Contacts
Public ContactAkira Tsuburaya
Kanagawa Cancer Center Gastro-Intestinal Surgery
Outcome results
None listed