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Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy

Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy - Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034478
Enrollment
20
Registered
2018-10-15
Start date
2018-06-01
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, gastric cancer, colorectal cancer, esophageal cancer, gynecological cancer

Interventions

Before the start of treatment the patient receives clear oral and written instructions on the use of Cooral by the nurse responsible for the patient. The patient him/herself is able to administer the

Sponsors

NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients for planning to administer alkylating agents, platinum, anthracycline, antimetabolite, or taxanes. 2. Out patients. 3. To write diary every day. 4. To obtain written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have infectious disease 2. Patients who have any oral disease and not able to wear the mouth device. ( Patients can include that they are able to wear the device although they have any oral disease. ) 3. Patients of oral cancer. 4. Patients who have received prior radiotherapy for oral. 5. Patients who have received bolus administration of chemotherapy agents.

Design outcomes

Primary

MeasureTime frame
Feasibility for Cooral system during the first chemotherapy cycle.

Secondary

MeasureTime frame
1.Grade of oral mucositis according to NCI-CTCAE. 2.Patient reported outcome of impression of use. 3.Patients' diary of oral mucositis measured. 4.Rating of oral pain measured with a Numerical Rating Scale. 5.Feasibility for Cooral system during the subsequently cycles.

Countries

Japan

Contacts

Public ContactAkiko Konomatsu

NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL Pharmacy

akk-koo@nms.ac.jp044-733-5181

Outcome results

None listed

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