Back to resultsWhite Tea for Prevention of Chemotherapy Induced Mucositis
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
White tea
Salt water with soda
Sponsored by
About this trial
This is an interventional prevention trial for Oral Mucositis focused on measuring mucositis, mouth, paclitaxel
Eligibility Criteria
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
Sites / Locations
- Department of Oncology, Vejle Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
White tea
Salt water with soda
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Frequency of daily mouthwashes
Number of daily mouthwashes will be registered
Frequency of daily tooth brushings
Number of daily tooth brushings will be registered
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04440930
Brief Title
White Tea for Prevention of Chemotherapy Induced Mucositis
Official Title
Can White Tea Prevent Oral Mucositis in Patients Receiving Neoadjuvant or Adjuvant Treatment With Paclitaxel for Breast Cancer? A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
mucositis, mouth, paclitaxel
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
White tea
Arm Type
Experimental
Arm Title
Salt water with soda
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
White tea
Intervention Description
Mouthwash with white tea five to six times a day for nine weeks
Intervention Type
Other
Intervention Name(s)
Salt water with soda
Intervention Description
Mouthwash with salt water and soda eight to ten times a day for nine weeks
Primary Outcome Measure Information:
Title
Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide.
Description
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).
Time Frame
up to nine weeks
Secondary Outcome Measure Information:
Title
Frequency of daily mouthwashes
Description
Number of daily mouthwashes will be registered
Time Frame
once a week over a period of nine weeks
Title
Frequency of daily tooth brushings
Description
Number of daily tooth brushings will be registered
Time Frame
once a week over a period of nine weeks
Title
Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS).
Description
Numeric Rating Scale 0-10; 0=no pain, 10=worst possible pain
Time Frame
Once a week over a period of nine weeks
Title
Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide.
Description
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).
Time Frame
Once a week until oral mucositis occurs up to nine weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik H Jakobsen, MD
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, Vejle Hospital
City
Vejle
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
White Tea for Prevention of Chemotherapy Induced Mucositis
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