NCT02467686

Breast Cancer, Sexuality and Black Cohosh

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo · Academic / Other
• Sex: Female
• Age: 48 Years – 68 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Sexuality

Interventions

Type	Name	Description
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.
BEHAVIORAL	FSFI questionnaire	FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
BEHAVIORAL	kupperman scale	Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
DRUG	Cimicifuga racemosa	The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2015-06-10
• Last updated: 2017-03-20

Locations

1 site across 1 country: Brazil