Breast Cancer, Sexuality and Black Cohosh
Nyckelord
Abstrakt
Beskrivning
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.
Datum
| Senast verifierad: | 02/28/2017 |
| Först skickat: | 03/03/2015 |
| Beräknad anmälan inlämnad: | 06/08/2015 |
| Först publicerad: | 06/09/2015 |
| Senaste uppdatering skickad: | 03/16/2017 |
| Senaste uppdatering publicerad: | 03/19/2017 |
| Faktiskt startdatum för studien: | 12/31/2013 |
| Uppskattat primärt slutdatum: | 08/31/2017 |
| Beräknat slutfört datum: | 11/30/2017 |
Tillstånd eller sjukdom
Intervention / behandling
Behavioral: WHOQOL questionnaire
Behavioral: FSFI questionnaire
Behavioral: kupperman scale
Drug: Cimicifuga racemosa
Drug: tamoxifen
Drug: exemestane
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| 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. |
Urvalskriterier
| Åldrar berättigade till studier | 48 Years Till 48 Years |
| Kön som är berättigade till studier | Female |
| Accepterar friska volontärer | Ja |
| Kriterier | 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 |
Resultat
Primära resultatåtgärder
1. Hot flashes (score of hot flashes) [6 months]
Sekundära resultatåtgärder
1. Sexual function (score of sexual function questionnaire (FSFI) [3 months]
2. Sexual function (score of sexual function questionnaire (FSFI) [6 months]
Andra resultatåtgärder
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]
