Breast Cancer, Sexuality and Black Cohosh

Sexuality Clinical Trial

— Cimicifuga  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02467686
• Other study ID #: 349441
• Status: Recruiting
• Phase: Phase 4
• First received: March 4, 2015
• Last updated: March 17, 2017
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Contact: Carolina Macruz
• Phone: +5511999141447
• Email: carolmacruz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexuality

Intervention

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.
• FSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
• 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
• tamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
• exemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.

Locations

Country	Name	City	State
Brazil	Carolina Furtado Macruz	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life (questionnaire scores of quality of life (WHOQOL)	Determine the questionnaire scores of quality of life (WHOQOL)	3 months
Other	Quality of life (questionnaire scores of quality of life (WHOQOL)	Determine the questionnaire scores of quality of life (WHOQOL)	6 months
Primary	Hot flashes (score of hot flashes)	Determine the score of hot flashes	6 months
Secondary	Sexual function (score of sexual function questionnaire (FSFI)	Determine the score of sexual function questionnaire (FSFI)	3 months
Secondary	Sexual function (score of sexual function questionnaire (FSFI)	Determine the score of sexual function questionnaire (FSFI)	6 months