Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cimicifuga racemosa | Active Comparator | 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. |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHOQOL questionnaire | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hot flashes (score of hot flashes) | Determine the score of hot flashes | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function (score of sexual function questionnaire (FSFI) | Determine the score of sexual function questionnaire (FSFI) | 3 months |
| Sexual function (score of sexual function questionnaire (FSFI) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (questionnaire scores of quality of life (WHOQOL) | Determine the questionnaire scores of quality of life (WHOQOL) | 3 months |
| Quality of life (questionnaire scores of quality of life (WHOQOL) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Macruz | Contact | +5511999141447 | carolmacruz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Black cohosh | Irmandade da Santa Casa Misericordia Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Furtado Macruz | Recruiting | São Paulo | São Paulo | 01225001 | Brazil |
When I have finished my recruitment and analysis of the results.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| C000713173 | black cohosh root extract |
| D013629 | Tamoxifen |
| C056516 | exemestane |
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| FSFI questionnaire | Behavioral | FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up. |
|
|
| kupperman scale | Behavioral | Kupperman scale is a tool to help evaluate the severity of menopausal symptoms |
|
|
| Cimicifuga racemosa | Drug | The Cimicifuga racemosa effects on the sexuality of women with Breast cancer |
|
|
| tamoxifen | Drug | The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen |
|
| exemestane | Drug | The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor. |
|
|
Determine the score of sexual function questionnaire (FSFI)
| 6 months |
Determine the questionnaire scores of quality of life (WHOQOL)
| 6 months |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |