Breast Cancer, Sexuality and Black Cohosh
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 02/28/2017 |
| İlk Gönderilen: | 03/03/2015 |
| Tahmini Kayıt Gönderildi: | 06/08/2015 |
| İlk Gönderilen: | 06/09/2015 |
| Son Güncelleme Gönderildi: | 03/16/2017 |
| Son Güncelleme Gönderildi: | 03/19/2017 |
| Fiili Çalışma Başlangıç Tarihi: | 12/31/2013 |
| Tahmini Birincil Tamamlanma Tarihi: | 08/31/2017 |
| Tahmini Çalışma Tamamlanma Tarihi: | 11/30/2017 |
Durum veya hastalık
Müdahale / tedavi
Behavioral: WHOQOL questionnaire
Behavioral: FSFI questionnaire
Behavioral: kupperman scale
Drug: Cimicifuga racemosa
Drug: tamoxifen
Drug: exemestane
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| 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. |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 48 Years İçin 48 Years |
| Çalışmaya Uygun Cinsiyetler | Female |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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 |
Sonuç
Birincil Sonuç Ölçütleri
1. Hot flashes (score of hot flashes) [6 months]
İkincil Sonuç Ölçütleri
1. Sexual function (score of sexual function questionnaire (FSFI) [3 months]
2. Sexual function (score of sexual function questionnaire (FSFI) [6 months]
Diğer Sonuç Ölçütleri
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]
