White Tea for Prevention of Chemotherapy Induced Mucositis
Słowa kluczowe
Abstrakcyjny
Opis
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.
Daktyle
| Ostatnia weryfikacja: | 05/31/2020 |
| Pierwsze przesłane: | 06/17/2020 |
| Szacowana liczba przesłanych rejestracji: | 06/18/2020 |
| Wysłany pierwszy: | 06/21/2020 |
| Ostatnia aktualizacja przesłana: | 06/21/2020 |
| Ostatnia opublikowana aktualizacja: | 06/24/2020 |
| Rzeczywista data rozpoczęcia badania: | 07/31/2020 |
| Szacowana data zakończenia podstawowej działalności: | 06/30/2021 |
| Szacowana data zakończenia badania: | 01/30/2022 |
Stan lub choroba
Interwencja / leczenie
Other: White tea
Other: Salt water with soda
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: White tea | Other: White tea Mouthwash with white tea five to six times a day for nine weeks |
| Active Comparator: Salt water with soda | Other: Salt water with soda Mouthwash with salt water and soda eight to ten times a day for nine weeks |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | Female |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | 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 |
Wynik
Podstawowe miary wyników
1. Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide. [up to nine weeks]
Miary wyników wtórnych
1. Frequency of daily mouthwashes [once a week over a period of nine weeks]
2. Frequency of daily tooth brushings [once a week over a period of nine weeks]
3. Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS). [Once a week over a period of nine weeks]
4. Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide. [Once a week until oral mucositis occurs up to nine weeks]
