Breast Cancer, Sexuality and Black Cohosh (Cimicifuga)

Irmandade da Santa Casa de Misericordia de Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Sexuality

Treatments: Drug: exemestane; Behavioral: kupperman scale; Behavioral: FSFI questionnaire; Drug: tamoxifen; Drug: Cimicifuga racemosa; Behavioral: WHOQOL questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02467686

349441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 48 to 68 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Cimicifuga racemosa

Active Comparator group

Description:

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.

Treatment:

Drug: tamoxifen

Behavioral: WHOQOL questionnaire

Drug: Cimicifuga racemosa

Behavioral: FSFI questionnaire

Behavioral: kupperman scale

Drug: exemestane

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: tamoxifen

Behavioral: WHOQOL questionnaire

Behavioral: FSFI questionnaire

Behavioral: kupperman scale

Drug: exemestane