White Tea for Prevention of Chemotherapy Induced Mucositis
کلید واژه ها
خلاصه
شرح
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.
تاریخ
| آخرین تأیید شده: | 05/31/2020 |
| اولین ارسال: | 06/17/2020 |
| ثبت نام تخمینی ارسال شد: | 06/18/2020 |
| اولین ارسال: | 06/21/2020 |
| آخرین بروزرسانی ارسال شده: | 06/21/2020 |
| آخرین به روزرسانی ارسال شده: | 06/24/2020 |
| تاریخ شروع مطالعه واقعی: | 07/31/2020 |
| تاریخ تخمین اولیه اولیه: | 06/30/2021 |
| تاریخ برآورد مطالعه: | 01/30/2022 |
شرایط یا بیماری
مداخله / درمان
Other: White tea
Other: Salt water with soda
فاز
گروههای بازو
| بازو | مداخله / درمان |
|---|---|
| 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 |
معیارهای صلاحیت
| سنین واجد شرایط تحصیل | 18 Years به 18 Years |
| جنسیت واجد شرایط مطالعه | Female |
| داوطلبان سالم را می پذیرد | آره |
| شاخص | 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 |
نتیجه
اقدامات اولیه
1. Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide. [up to nine weeks]
اقدامات ثانویه
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]
