White Tea for Prevention of Chemotherapy Induced Mucositis
Fjalë kyçe
Abstrakt
Përshkrim
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.
Datat
| Verifikuar së fundmi: | 05/31/2020 |
| Paraqitur së pari: | 06/17/2020 |
| Regjistrimi i vlerësuar u dorëzua: | 06/18/2020 |
| Postuar së pari: | 06/21/2020 |
| Përditësimi i fundit i paraqitur: | 06/21/2020 |
| Përditësimi i fundit i postuar: | 06/24/2020 |
| Data e fillimit të studimit aktual: | 07/31/2020 |
| Data e vlerësuar e përfundimit primar: | 06/30/2021 |
| Data e vlerësimit të përfundimit të studimit: | 01/30/2022 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Other: White tea
Other: Salt water with soda
Faza
Grupet e krahëve
| Krah | Ndërhyrja / trajtimi |
|---|---|
| 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 |
Kriteret e pranimit
| Moshat e pranueshme për studim | 18 Years Për të 18 Years |
| Gjinitë e pranueshme për studim | Female |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | 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 |
Rezultati
Masat Kryesore të Rezultateve
1. Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide. [up to nine weeks]
Masat dytësore të rezultateve
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]
