- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440930
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hrønn Thorn
- Phone Number: 7940 6803
- Email: Hronn.Thorn@rsyd.dk
Study Locations
-
-
-
Vejle, Denmark
- Department of Oncology, Vejle Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: White tea
|
Mouthwash with white tea five to six times a day for nine weeks
|
Active Comparator: 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.
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).
|
up to nine weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of daily mouthwashes
Time Frame: once a week over a period of nine weeks
|
Number of daily mouthwashes will be registered
|
once a week over a period of nine weeks
|
Frequency of daily tooth brushings
Time Frame: once a week over a period of nine weeks
|
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).
Time Frame: Once a week over a period of nine weeks
|
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.
Time Frame: 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).
|
Once a week until oral mucositis occurs up to nine weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Erik H Jakobsen, MD, Vejle Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHITE TEA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Mucositis
-
Air Force Military Medical University, ChinaNot yet recruitingMucositis OralChina
-
University Hospital, ToulouseRecruiting
-
Catalysis SLCompletedMucositis OralRussian Federation
-
Ghada zakiNot yet recruiting
-
Galera Therapeutics, Inc.CompletedRadiation Induced Oral MucositisUnited States, Canada, Puerto Rico
-
Al-Azhar UniversityCompletedStomatitis (Oral Mucositis)Egypt
-
Cairo UniversityNot yet recruitingChemotherapy Induced Oral Mucositis
-
University of Science and Technology, YemenCompletedChemotherapy-induced Oral Mucositis
-
Tata Memorial CentreRecruitingOral Mucositis (Ulcerative)India
Clinical Trials on White tea
-
University of ZurichCOOPCompleted
-
Providence Health & ServicesCompletedMetastatic Sarcoma | Metastatic Carcinoma | Metastatic LymphomaUnited States
-
Yağmur Saraç GülRecep Tayyip Erdogan University Scientific Research Projects CoordinatorCompletedInflammation | Oxidative Stress | Gingivitis; ChronicTurkey
-
University of ArizonaUnited States Department of DefenseCompletedLung Cancer Prevention
-
University of CoimbraCompletedCommunicationPortugal
-
National Taiwan University HospitalRecruitingHyperglycemia | Type 2 Diabetes | HyperlipidemiaTaiwan
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustCompleted
-
University of Missouri-ColumbiaCompletedGlucose | Blood Sugar; High | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Organización Interprofesional Agroalimentaria de...Universidad de GranadaCompleted
-
Celal Bayar UniversityNot yet recruitingNewborn | Breastfeeding | Music | MotherTurkey