White Tea for Prevention of Chemotherapy Induced Mucositis

  • STATUS
    Recruiting
  • End date
    Jul 11, 2023
  • participants needed
    88
  • sponsor
    Vejle Hospital
Updated on 11 March 2022
paclitaxel
cancer
mucositis

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.

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.

Details
Condition Oral Mucositis
Treatment White tea, Salt water with soda
Clinical Study IdentifierNCT04440930
SponsorVejle Hospital
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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