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

The evaluation of supportive care for stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin - Doxil trial for stomatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004272
Enrollment
42
Registered
2010-09-28
Start date
2010-09-01
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

a) Dentistry consultation until DOXIL treatment two weeks before b) Self-brushing and moisture retention in the oral cavity c) Gargling with aznol saline gargle d) Internal use of Rebamipide(300mg/

Sponsors

Japan Doxil study group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin (50mg/m2 or 40mg/m2). The period from final chemotherapy should not be over 12 months. All patients should not have measurable lesions with the RECIST 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

MeasureTime frame
The incidence of more than grade2 stomatitis—

Secondary

MeasureTime frame
The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to stomatitis The incidence of adverse event except for stomatitis The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to adverse event except for stomatitis—

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