Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004287
- Lead Sponsor
- PO Epidemiological and Clinical Research Information Network (ECRIN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
(1)blood transfusion or hemopoietic factors (e.g.G-CSF) within 7 days . (2)Not using traditional Japanese medicines (Kampo) within 2 weeks. (3)Serious drug allergy.. (4)Current analgesic treatment. (5)Neuropathy or sensory dysfunction. (6)Active double cancer. (7)Uncontrolled pleural effusion or ascites. (8)Clinically significant infection. (9)Brain metastasis. (10)Clinically significant electrocardiographic abnormality. (11)Clinically significant heart disease (myocardial infarction within 12 months, etc.). (12)Clinically significant pulmonary disease (13)Gastrointestinal bleeding that requires medication or transfusion. (14)Watery diarrhea.. (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of oral mucositis. grade>=2
- Secondary Outcome Measures
Name Time Method
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