White Tea for Prevention of Chemotherapy Induced Mucositis

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Other: White tea; Other: Salt water with soda

• Registration Number: NCT04440930
• Lead Sponsor: Vejle Hospital

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 Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Study Start: 2020-09-02
• Primary Completion: 2023-03-28
• Study Completion: 2023-04-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White tea	White tea	-
Salt water with soda	Salt water with soda	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
Frequency of daily mouthwashes	once a week over a period of nine weeks	Number of daily mouthwashes will be registered

Trial Locations

Locations (1)

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark