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The aim of this study is to determine the effectiveness of mouthwash with white tea in the prevention of paclitaxel induced oral mucositis in women with breast cancer.
Oral mucositis is a common side effect from paclitaxel treatment. It can be very painful and compromise nutrition and oral hygiene, and it may increase the risk of infection. Although oral mucositis is a common side effect to chemotherapy, no available treatment is yet available that can effectively prevent or treat oral mucositis.
Based on the knowledge that white tea has anti-inflammatory, anti-oxidant and anti-microbial effect, the current study aims to assess the effect of mouth wash with white tea on paclitaxel induced oral mucositis in women with breast cancer.
This study is a phase II randomized controlled trial in which eligible patients will be allocated to a control group (CG) and a study group (SG). The CG will use salt water with soda for mouthwash eight to ten times a day and the SG will use white tea for mouthwash five to six times a day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White tea | Experimental |
| |
| Salt water with soda | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White tea | Other | Mouthwash with white tea five to six times a day for nine weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide. | Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems). | up to nine weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of daily mouthwashes | Number of daily mouthwashes will be registered | once a week over a period of nine weeks |
| Frequency of daily tooth brushings | Number of daily tooth brushings will be registered |
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Inclusion Criteria:
Exclusion Criteria:
- Palliative treatment with paclitaxel
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| Name | Affiliation | Role |
|---|---|---|
| Erik H Jakobsen, MD | Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | Denmark |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Salt water with soda |
| Other |
Mouthwash with salt water and soda eight to ten times a day for nine weeks |
|
| once a week over a period of nine weeks |
| Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS). | Numeric Rating Scale 0-10; 0=no pain, 10=worst possible pain | Once a week over a period of nine weeks |
| Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide. | Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems). | Once a week until oral mucositis occurs up to nine weeks |
| D004066 |
| Digestive System Diseases |