Clinical trial to assess the efficacy of adapalene for hand-foot syndrome (HFS) in patients of metastatic breast cancer
Not Applicable
Recruiting
- Conditions
- metastatic breast cancer
- Registration Number
- JPRN-UMIN000011772
- Lead Sponsor
- Department of gastroenterologic and breast surgery Kanazawa University,School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1)Past history of allergic reaction 2)Active secondary malignancies 3)Pregnancy or suspected pregnancy 4)Uncontralled severe infection 5)severe complications (uncontrolled hypertension, angina pectoris, congestive heart disease, liver failure, prior myocardial infarction in less than a year, arrhythmia requiring treatment, or bleeding tendency) 6)Dyspnea requiring oxygen therapy because of interstitial pneumonia or pulmonary fibrosis 7)Symptomatic brain metastasis 8)Uncontrolled diabetes mellitus 9)Severe pleural effusion or ascites 10)Physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inhibition ratio of HFS on the applied hand and foot of adapalene to the opposite sides Inhibiton ratio of HFS: number of cases which have successful treatment with adapalene / number of cases with HFS induced by capecitabine
- Secondary Outcome Measures
Name Time Method Percentage of patients with hand-foot syndrome on the applied hand and foot of adapalene or on the opposite side Time to the onset of hand-foot syndrome according to grade of HFS Progression-free Survival (PFS) Overall Response Rate (ORR) Incidence of an adverse event