White Tea for Prevention of Chemotherapy Induced Mucositis

Vejle Hospital

Status: Completed

Conditions: Oral Mucositis

Treatments: Other: White tea; Other: Salt water with soda

Study type: Interventional

Funder types: Other

Identifiers

NCT04440930

WHITE TEA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

White tea

Experimental group

Treatment:

Other: White tea

Salt water with soda

Active Comparator group

Treatment:

Other: Salt water with soda