The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubici
Not Applicable
- Conditions
- Recurrent/ Relapsed M&uumlllerian carcinoma
- Registration Number
- JPRN-UMIN000001976
- Lead Sponsor
- Japan Doxil study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 86
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients having fever over 38.0 2.Patients with infection 3.Patients with severe complications 4.Patients with double cancer 5.Patients with massive pleural effusion, ascites and pericardial fluid need to continuous drainage 6.Patients received chemotherapy including anthracycline 7.Patients with brain metastasis 8.Patient with previous hypersensitivity reaction to doxorubicin HCL or component of pegylated liposomal doxorubicin 9.Gravida, patients with lactation and with intent to pregnancy 10.Patients judged as the exclusive case by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of more than grade2 hand-foot syndrome
- Secondary Outcome Measures
Name Time Method The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to hand-foot syndrome The incidence of more than grade2 stomatitis The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to stomatitis The incidence of adverse event except for hand-foot syndrome and stomatitis The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to adverse event except for hand-foot syndrome and stomatitis Dose intensity of pegylated liposomal doxorubicin Response rate