White Tea for Prevention of Chemotherapy Induced Mucositis

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440930
• Other study ID #: WHITE TEA
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 30, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Other:
• White tea
Mouthwash with white tea five to six times a day for nine weeks
• Salt water with soda
Mouthwash with salt water and soda eight to ten times a day for nine weeks

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Frequency of daily mouthwashes	Number of daily mouthwashes will be registered	once a week over a period of nine weeks
Secondary	Frequency of daily tooth brushings	Number of daily tooth brushings will be registered	once a week over a period of nine weeks
Secondary	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
Secondary	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