NCT04440930

White Tea for Prevention of Chemotherapy Induced Mucositis

Can White Tea Prevent Oral Mucositis in Patients Receiving Neoadjuvant or Adjuvant Treatment With Paclitaxel for Breast Cancer? A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
OTHER	White tea	Mouthwash with white tea five to six times a day for nine weeks
OTHER	Salt water with soda	Mouthwash with salt water and soda eight to ten times a day for nine weeks

Timeline

• Start date: 2020-09-02
• Primary completion: 2023-03-28
• Completion: 2023-04-30
• First posted: 2020-06-22
• Last updated: 2023-09-05

Locations

1 site across 1 country: Denmark