White Tea for Prevention of Chemotherapy Induced Mucositis

NCT ID: NCT04440930

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2023-04-30

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.

Conditions

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Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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White tea

Group Type EXPERIMENTAL

White tea

Intervention Type OTHER

Mouthwash with white tea five to six times a day for nine weeks

Salt water with soda

Group Type ACTIVE_COMPARATOR

Salt water with soda

Intervention Type OTHER

Mouthwash with salt water and soda eight to ten times a day for nine weeks

Interventions

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White tea

Mouthwash with white tea five to six times a day for nine weeks

Intervention Type OTHER

Salt water with soda

Mouthwash with salt water and soda eight to ten times a day for nine weeks

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik H Jakobsen, MD

Role: STUDY_CHAIR

Vejle Hospital

Locations

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Department of Oncology, Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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WHITE TEA

Identifier Type: -

Identifier Source: org_study_id

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