Short 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.

Rationale

Oral mucositis is a common side effect from paclitaxel therapy. Oral mucositis can be very painful and comprise nutrition and oral hygiene and may increase the risk for infection.  Although oral mucositis is a common side effect to chemotherapy no available treatment is yet found that can effectively prevent or treat oral mucositis. 

Based on the knowledge  that white tea  have 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) or to 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.   

Description of the cohort

Adult women with breastcancer treated with paclitaxel

Data and biological material

Primary outcome: Incidence of oral mucositis of grade 2 or higher measured on Revised Oral Assessment Guide (ROAG) once a week over a period of nine weeks

Secondary outcomes: Frequency of daily mouthwash

Frequency of daily tooth brushing

Pain intensity in the oral cavity measured on

Day of onset of oral mucositis of grade 2 or higher measured on ROAG