Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.

UMIN ID: UMIN000013281

Registered date:03/03/2014

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: head and neck cancer, oral cancer
• Date of first enrollment: 2014/03/03
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Control group: Patients gargles with azulene sodium sulfonate three times a day since treatment start.
Hange-shashin-to group: Patients gargles with Hange-shashin-to three times a day since treatment start.

Outcome(s)

Primary Outcome

Objective evaluation: CTCAE ver.4.0, food requirement, blood examination(total protein, albumin, inflammatory cytokine, etc)
Subjective assesment: patients questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: The patients uses gargling before treatment.

Related Information

• Primary Sponsor: Shinshu University School of Medicine
• Source(s) of Monetary Support: Shinshu University Hospital