Breast Cancer, Sexuality and Black Cohosh

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Cimicifuga Racemosa L. Nutt Sexuality of Women With Breast Cancer Using Tamoxifen or Aromatase Inhibitor

Conditions
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Sexuality

Intervention / Treatment
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* Behavioral: WHOQOL questionnaire
* Behavioral: FSFI questionnaire
* Behavioral: kupperman scale
* Drug: Cimicifuga racemosa
* Drug: tamoxifen
* Drug: exemestane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cimicifuga racemosa<br>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<br>* 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.<br>* Other names: The World Health Organization Quality of Life;Behavioral: FSFI questionnaire<br>* FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.<br>* Other names: Female sexual function index (FSFI) questionnaire;Behavioral: kupperman scale<br>* Kupperman scale is a tool to help evaluate the severity of menopausal symptoms<br>* Other names: Blatt-Kupperman menopausal index;Drug: Cimicifuga racemosa<br>* The Cimicifuga racemosa effects on the sexuality of women with Breast cancer<br>* Other names: Black Cohosh;Drug: tamoxifen<br>* The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen<br>Drug: exemestane<br>* The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.<br>* Other names: aromatase inhibitor;|
| Placebo Comparator: Control<br>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<br>* 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.<br>* Other names: The World Health Organization Quality of Life;Behavioral: FSFI questionnaire<br>* FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.<br>* Other names: Female sexual function index (FSFI) questionnaire;Behavioral: kupperman scale<br>* Kupperman scale is a tool to help evaluate the severity of menopausal symptoms<br>* Other names: Blatt-Kupperman menopausal index;Drug: tamoxifen<br>* The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen<br>Drug: exemestane<br>* The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.<br>* Other names: aromatase inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flashes (score of hot flashes) | Determine the score of hot flashes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | Determine the score of sexual function questionnaire (FSFI) | 6 months |