Breast Cancer, Sexuality and Black Cohosh
Keywords
Coimriú
Cur síos
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.
Dátaí
| Fíoraithe Deireanach: | 02/28/2017 |
| Cuireadh isteach den chéad uair: | 03/03/2015 |
| Clárú Measta Curtha isteach: | 06/08/2015 |
| Arna chur suas ar dtús: | 06/09/2015 |
| Nuashonrú Deireanach Curtha isteach: | 03/16/2017 |
| Nuashonrú Deireanach Postáilte: | 03/19/2017 |
| Dáta Tosaigh an Staidéir Iarbhír: | 12/31/2013 |
| Dáta Críochnaithe Bunscoile Measta: | 08/31/2017 |
| Dáta Críochnaithe an Staid Mheasta: | 11/30/2017 |
Coinníoll nó galar
Idirghabháil / cóireáil
Behavioral: WHOQOL questionnaire
Behavioral: FSFI questionnaire
Behavioral: kupperman scale
Drug: Cimicifuga racemosa
Drug: tamoxifen
Drug: exemestane
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| 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. |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 48 Years Chun 48 Years |
| Gnéas Incháilithe le haghaidh Staidéir | Female |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | 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 |
Toradh
Bearta Toraidh Príomhúla
1. Hot flashes (score of hot flashes) [6 months]
Bearta Torthaí Tánaisteacha
1. Sexual function (score of sexual function questionnaire (FSFI) [3 months]
2. Sexual function (score of sexual function questionnaire (FSFI) [6 months]
Bearta Toraidh Eile
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]
