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Completed

NCT Number: NCT04440930

White Tea for Prevention of Chemotherapy Induced Mucositis

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.

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Key information

Conditions

Oral Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Vejle Hospital

Vejle, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

White tea

Other

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

Salt water with soda

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Frequency of daily mouthwashes

    Time frame: once a week over a period of nine weeks

    Number of daily mouthwashes will be registered

  2. Frequency of daily tooth brushings

    Time frame: once a week over a period of nine weeks

    Number of daily tooth brushings will be registered

  3. 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

  4. 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).

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2020
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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