White Tea for Prevention of Chemotherapy Induced Mucositis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Other: White tea
* Other: Salt water with soda


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucositis, mouth, paclitaxel