Can White Tea Prevent Oral Mucositis in Patients Receiving Neoadjuvant or Adjuvant Treatment With Paclitaxel for Breast Cancer? A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vejle Hospital
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
White tea
Intervention: White tea (Other)
Salt water with soda
Intervention: Salt water with soda (Other)
Outcomes
Primary Outcomes
Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide.
Time Frame: 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 Outcomes
- Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS).(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.(Once a week until oral mucositis occurs up to nine weeks)
- Frequency of daily tooth brushings(once a week over a period of nine weeks)
- Frequency of daily mouthwashes(once a week over a period of nine weeks)