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

The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed M&uuml;llerian carcinoma received chemotherapy of pegylated liposomal doxorubicin - Doxil trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001976

Enrollment

Registered

2009-05-18

Start date

2009-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent/ Relapsed M&amp

Interventions

Local Cooling Pridoxine treatment Dexamethasone treatment Education for patients

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients with recurrent/ relapsed M&uuml;llerian carcinoma received chemotherapy of pegylated liposomal doxorubicin. The period from final chemotherapy should not be over 12 months. All patients should not have measurable lesions with the RECIST criteria. If the diagnosis of recurrence or relapse with only escalation of serum CA125, the diagnosis should be based on the definition of CA125 progression (GCIG criteria). 2. Performance status: 0-2 3. Age: More than 20 years old 4. Patients without severe dysfunction of major organs 5. Patients can be alive over 4 months after treatment 6. Patients must have signed informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The incidence of more than grade2 hand-foot syndrome	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactMuneaki Shimada

Faculty of Medicine, Tottori University Division of Reproductive-Perinatal medicine and Gynecologic Oncology

mshima12@med.tottori-u.ac.jp0859-38-6647

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed M&amp;uuml;llerian carcinoma received chemotherapy of pegylated liposomal doxorubicin