Oral MucositisNCT04440930
White Tea for Prevention of Chemotherapy Induced Mucositis
A study testing White tea and Salt water with soda in people with Oral Mucositis, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- White tea and Salt water with soda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Sep 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with breast cancer
- Planned neoadjuvant or adjuvant paclitaxel treatment
- Age ≥ 18 years
- Understand and speak Danish
- Written and orally informed consent
Who cannot join
- Palliative treatment with paclitaxel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Mucositis
- Being tested
- White tea, Salt water with soda
- Keywords
- mucositis, mouth, paclitaxel
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White teaOther
Mouthwash with white tea five to six times a day for nine weeks
Salt water with sodaOther
Mouthwash with salt water and soda eight to ten times a day for nine weeks
| Study group | Role | What they receive |
|---|---|---|
| White tea | Experimental | Not described Receives: Other: White tea |
| Salt water with soda | Active comparator | Not described Receives: Other: Salt water with soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to nine weeks
Secondary outcomes (4)
Frequency of daily mouthwashes
Number of daily mouthwashes will be registered
Measured: once a week over a period of nine weeks
Frequency of daily tooth brushings
Number of daily tooth brushings will be registered
Measured: 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
Measured: 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).
Measured: Once a week until oral mucositis occurs up to nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start2 Sep 2020
- Primary completion28 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik H Jakobsen, MD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440930
- Sponsor's protocol ID
- WHITE TEA
- Status last verified
- Sep 2023
- First submitted
- 18 Jun 2020
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can White Tea Prevent Oral Mucositis in Patients Receiving Neoadjuvant or Adjuvant Treatment With Paclitaxel for Breast Cancer? A Randomized Trial
- ClinicalTrials.gov ID
- NCT04440930
- Acronym / sponsor ID
- WHITE TEA
- Conditions
- Oral Mucositis
- Keywords
- mucositis, mouth, paclitaxel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| White tea | Experimental | Other: White tea |
| Salt water with soda | Active comparator | Other: Salt water with soda |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Woman with breast cancer
- Planned neoadjuvant or adjuvant paclitaxel treatment
- Age ≥ 18 years
- Understand and speak Danish
- Written and orally informed consent
Key exclusion criteria (1 listed)
- Palliative treatment with paclitaxel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White teaMouthwash with white tea five to six times a day for nine weeks | Other | White tea |
| Salt water with sodaMouthwash with salt water and soda eight to ten times a day for nine weeks | Other | Salt water with soda |
Primary outcome
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).
4 secondary outcomes
Frequency of daily mouthwashes
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik H Jakobsen, MD study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White tea and Salt water with soda in people with Oral Mucositis, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide. (time frame: up to nine weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.