Multicenter randomized phase II study prevention of chemotherapy induced stomatitis with the steroid component mouthwash in woman with breast cancer
Phase 2
- Conditions
- breast cancerBreast cancer, chemotherapy induced stomatitis
- Registration Number
- JPRN-jRCTs071180022
- Lead Sponsor
- Eguchi Susumu
- Brief Summary
We conducted a multicenter, randomized, controlled phase II trial. Patients with early-stage breast cancer scheduled for epirubicin and cyclophosphamide (EC) or taxotere and cyclophosphamide (TC) therapies were allocated in a 1:1 ratio to the study and control groups.The incidence of stomatitis was 55% in the control group and 38% in the study group. The grade of stomatitiswas significantly lower in the study group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 121
Inclusion Criteria
Patients who is going to have chemotherapy, patients without stomatitis
Exclusion Criteria
Patients who have metastatic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of all grade stomatitis
- Secondary Outcome Measures
Name Time Method Incidence of stomatitis according grade, Incidence of dysgeusia, nutrition status, completion rates of chemotherapy, relative dose intensity