Cimicifuga: Breast Cancer, Sexuality and Black Cohosh
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen or aromatase inhibitor through questionnaires.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Behavioral: WHOQOL questionnaire
WHO defines Quality of Life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Other Names:
Behavioral: FSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
Other Names:
Behavioral: kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Other Names:
Drug: Cimicifuga racemosa
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
Other Names:
Drug: tamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
Drug: exemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
Other Names:
|
| 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. |
Behavioral: WHOQOL questionnaire
WHO defines Quality of Life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Other Names:
Behavioral: FSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
Other Names:
Behavioral: kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Other Names:
Drug: tamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
Drug: exemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hot flashes (score of hot flashes) [6 months]
Determine the score of hot flashes
Secondary Outcome Measures
- Sexual function (score of sexual function questionnaire (FSFI) [3 months]
Determine the score of sexual function questionnaire (FSFI)
- Sexual function (score of sexual function questionnaire (FSFI) [6 months]
Determine the score of sexual function questionnaire (FSFI)
Other Outcome Measures
- Quality of life (questionnaire scores of quality of life (WHOQOL) [3 months]
Determine the questionnaire scores of quality of life (WHOQOL)
- Quality of life (questionnaire scores of quality of life (WHOQOL) [6 months]
Determine the questionnaire scores of quality of life (WHOQOL)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolina Furtado Macruz | Sao Paulo | Brazil | 01225001 |
Sponsors and Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
- Principal Investigator: Black cohosh, Irmandade da Santa Casa Misericordia Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 349441