The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin

UMIN ID: UMIN000001976

Registered date:18/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Recurrent/ Relapsed Müllerian carcinoma
• Date of first enrollment: 2009/05/01
• Target sample size: 86
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Local Cooling Pridoxine treatment Dexamethasone treatment Education for patients

Outcome(s)

• Primary Outcome: The incidence of more than grade2 hand-foot syndrome
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Doxil study group
• Secondary Sponsor: SGSG, TGCU, GOTIC
• Source(s) of Monetary Support: Gynecological Tumor Support Organization