Phase II randomized study to investigate the effectiveness of Hangeshashinto(TJ-14) against chemoradiation-induced oral and pharyngeal mucositis
Phase 2
Recruiting
- Conditions
- head and neck cancer
- Registration Number
- JPRN-UMIN000012948
- Lead Sponsor
- Department of Otolaryngolory-Head and Neck Surgery, National Defense Medical College of Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients administered other Kampo medicine within 2 weeks before registration 2) Patients who were continuously adminisiterd NSAIDs, opioids or steroids within one month before registration 3) Patients having serious comorbid disease 4) Patients administered a developing new drug 5) Pregnant patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of more than grade 3 oral mucositis by CTCAE Ver. 4.0
- Secondary Outcome Measures
Name Time Method 1) Rates of chemoradiation completion 2) Duration of presence of more than grade 3 oral mucositis 3) Days until incidence of more than grade 3 oral mucositis 4) Total dose of opioids 5) Change of body weight 6) Nutrition status 7) Use of tube feeding 8) Grade of Dry mouth by CTCAE version 4.0 more than 6 months after chemoradiation