Breast Cancer, Sexuality and Black Cohosh
关键词
抽象
描述
For the study will be recruited 60 women treated with breast cancer, using tamoxifen or aromatase inhibitor, are in menopause, hot flashes and has with or without sexual life. They will answer the questionnaires: Kupperman, World Health Organization Quality of Life (WHOQOL) and those sexually active will have Female Sexual Function Index (FSFI). The control group will have 30 patients using tamoxifen alone or inhibitor. The other group will have 30 patients receiving tamoxifen or inhibitor and will start with 2 tablets per day of dry extract of Cimicifuga racemosa. They will be followed for 6 months and answer questionnaires at the first visit, 3-month and 6-month follow-up.
日期
| 最后验证: | 02/28/2017 |
| 首次提交: | 03/03/2015 |
| 提交的预估入学人数: | 06/08/2015 |
| 首次发布: | 06/09/2015 |
| 上次提交的更新: | 03/16/2017 |
| 最近更新发布: | 03/19/2017 |
| 实际学习开始日期: | 12/31/2013 |
| 预计主要完成日期: | 08/31/2017 |
| 预计完成日期: | 11/30/2017 |
状况或疾病
干预/治疗
Behavioral: WHOQOL questionnaire
Behavioral: FSFI questionnaire
Behavioral: kupperman scale
Drug: Cimicifuga racemosa
Drug: tamoxifen
Drug: exemestane
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Cimicifuga racemosa The other group will have 30 patients receiving tamoxifen 20 mg orally daily or exemestane (aromatase inhibitor) 25 mg orally once daily after a meal and will start with 2 tablets per day of dry extract of Cimicifuga racemosa.
Each tablet contains 20 mg of dry extract of Cimicifuga racemosa standardized between 1 mg and 1.25 mg of triterpene glycosides expressed in 26-deoxyactein. Will be guided 1 tablet 12/12 hours for 6 months.
WHOQOL questionnaire (The World Health Organization Quality of life)application for evaluation at the first visit, 3-month and 6-month follow-up.
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up. | Drug: Cimicifuga racemosa The Cimicifuga racemosa effects on the sexuality of women with Breast cancer |
| Placebo Comparator: Control Control group will have 30 patients receiving tamoxifen 20 mg orally daily or exemestane (aromatase inhibitor) 25 mg orally once daily after a meal . They will be followed for 6 months and answer Kupperman scale, WHOQOL questionnaire and FSFI questionnaire at the first visit, 3-month and 6-month follow-up.
WHOQOL questionnaire (The World Health Organization Quality of life)application for evaluation at the first visit, 3-month and 6-month follow-up.
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up. |
资格标准
| 有资格学习的年龄 | 48 Years 至 48 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor. - With hot flashes and with or without active sexual life. Exclusion Criteria: - Women did not have breast cancer - do not use tamoxifen or aromatase inhibitor - not in menopause and not have hot flashes |
结果
主要结果指标
1. Hot flashes (score of hot flashes) [6 months]
次要成果指标
1. Sexual function (score of sexual function questionnaire (FSFI) [3 months]
2. Sexual function (score of sexual function questionnaire (FSFI) [6 months]
其他成果措施
1. Quality of life (questionnaire scores of quality of life (WHOQOL) [3 months]
2. Quality of life (questionnaire scores of quality of life (WHOQOL) [6 months]
