Oral Mucositis
Conditions
Keywords
mucositis, mouth, paclitaxel
Brief summary
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.
Detailed description
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.
Interventions
OTHERWhite tea
Mouthwash with white tea five to six times a day for nine weeks
OTHERSalt water with soda
Mouthwash with salt water and soda eight to ten times a day for nine weeks
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman with breast cancer * Planned neoadjuvant or adjuvant paclitaxel treatment * Age ≥ 18 years * Understand and speak Danish * Written and orally informed consent
Exclusion criteria
\- Palliative treatment with paclitaxel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide. | up to nine weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of daily mouthwashes | once a week over a period of nine weeks | Number of daily mouthwashes will be registered |
| Frequency of daily tooth brushings | once a week over a period of nine weeks | Number of daily tooth brushings will be registered |
| Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS). | Once a week over a period of nine weeks | Numeric Rating Scale 0-10; 0=no pain, 10=worst possible pain |
| Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide. | Once a week until oral mucositis occurs up to nine weeks | 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). |
Countries
Denmark
Outcome results
None listed