UMIN ID: UMIN000013281
Registered date:03/03/2014
Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.
Basic Information
| Public title | Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy. |
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| Scientific title | |
| Recruitment status | Pending |
| Health condition(s) or Problem(s) studied | head and neck cancer, oral cancer |
| Study type | Interventional |
| Phase | |
| Study design | |
| 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. |
| Sample Size | 60 |
| Date of first enrollment | 2014/03/03 |
| Completion date | None |
| Countries of recruitment | Japan |
Outcome(s)
| Primary Outcome | Objective evaluation: CTCAE ver.4.0, food requirement, blood examination(total protein, albumin, inflammatory cytokine, etc) Subjective assesment: patients questionnaire |
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| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
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| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | The patients, who suffered from oral cancer or head and neck cancer, planned chemotherapy and chemoradiotherapy. |
| Exclude criteria | The patients uses gargling before treatment. |
Related Information
| Primary Sponsor | Shinshu University School of Medicine |
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| Secondary | |
| Source(s) | Shinshu University Hospital |
Secondary Identifiers
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Contact
| public contact | |
| Name | Nodoka Sekiguchi |
| Address | 3-1-1 Asahi, Matsumoto, Nagano Japan |
| Telephone | 0263-35-4600 |
| nodokas@shinshu-u.ac.jp | |
| Affiliation | Shinshu University Department of Comprehensive Cancer Therapy |
| scientific contact | |
| Name | Nodoka Sekiguchi |
| Address | 3-1-1 Asahi, Matsumoto, Nagano Japan |
| Telephone | 0263-35-4600 |
| nodokas@shinshu-u.ac.jp | |
| Affiliation | Shinshu University Department of Comprehensive Cancer Therapy |
Ethics Reviews
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Summary Results
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| Outcome measures | |
| Brief Summary | |
| URL link to protocol file(s) with version and date |
IPD sharing statement
| Plan to share IPD | |
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