Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients

Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients - Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022582

Enrollment

Registered

2016-06-10

Start date

2016-04-01

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

breast cancer

Interventions

oral cryotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patients who had a diagnosis of invasive breast cancer by needle biopsy or tissue biopsy 2. FEC(EC)100/TC therapy enforcement planned patients 3. The patients who do not receive previous treatment for breast cancer 4. The patients who do not have oral mucositis before treatment 5. The patients without inadequate dentures 6. The patients that PS is 0-1 7. Age is women 80 years or younger 20 years old or older at the time of the agreement acquisition 8. The patients having more than 55% of left ventricular ejection fractions (LVEF) in an echocardiography 9. The patients without the abnormality clinical in an electrocardiogram 10. The patients that an agreement was obtained in a document

Exclusion criteria

Exclusion criteria: 1. Advanced or metastatic breast cancer 2. A pregnant woman and the patients who may be pregnant or the patients whom we are nursing 3. The patients whom a study person in charge judged to be inadequate as study patients

Design outcomes

Primary

Measure	Time frame
Rate of all grade oral mucositis	—

Countries

Japan

Contacts

Public ContactKuba Sayaka

Nagasaki University Graduate School of Biomedical Science Surgery

skuba@nagasaki-u.ac.jp095-849-7316

Outcome results

None listed

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