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

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Other: White tea; Other: Salt water with soda

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark
    • Department of Oncology, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: White tea	Other: White tea; Mouthwash with white tea five to six times a day for nine weeks
Active Comparator: Salt water with soda	Other: Salt water with soda; Mouthwash with salt water and soda eight to ten times a day for nine weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of daily mouthwashes	Number of daily mouthwashes will be registered	once a week over a period of nine weeks
Frequency of daily tooth brushings	Number of daily tooth brushings will be registered	once a week over a period of nine weeks
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
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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Erik H Jakobsen, MD, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: paclitaxel; mucositis; mouth
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: WHITE TEA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No