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Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study

Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study - Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050646
Enrollment
66
Registered
2023-03-22
Start date
2023-04-01
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

Head and neck cancer patients

Interventions

None listed

Sponsors

Gunma University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A Malignant tumor in the head and neck region. (2) The lesion is measurable. 3) Radiotherapy is planned. 4) The oral mucosa may be irradiated. 5) The patient is over 18 years of age. 6) Performance Status (PS) is 0-2. (7) The patient has been informed of the name and condition of the disease and is capable of consenting.

Exclusion criteria

Exclusion criteria: 1) Previous radiation therapy to the area to be treated. 2) Active and refractory infection at the irradiated site. (3) Severe complications (uncontrolled diabetes, myocardial infarction, unstable angina, uncontrolled arrhythmia, bleeding tendency, collagen disease requiring steroid administration, etc.). (4) Active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in the active overlapping cancers. (5) Previous surgery in the radiotherapy area. (6) An event occurs during the study period for which radiotherapy should not be initiated. (7) The patient is found not to have a malignant tumor in the head and neck region after the start of the study. (8) If it becomes difficult to continue radiotherapy for some reason after the start of the study. (9) Other medical, psychological, or other factors that make the physician in charge of the patient inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
To observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced mucositis.

Countries

Japan

Contacts

Public ContactAtsushi Musha

Gunma University Heavy Ion Medical Center

musha@gunma-u.ac.jp027-220-8378

Outcome results

None listed

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