Breast Cancer, Sexuality and Black Cohosh (Cimicifuga)

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

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.

Study Overview

• Status: Unknown
• Conditions: Sexuality
• Intervention / Treatment: Behavioral: WHOQOL questionnaire; Behavioral: FSFI questionnaire; Behavioral: kupperman scale; Drug: Cimicifuga racemosa; Drug: tamoxifen; Drug: exemestane

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carolina Macruz; Phone Number: +5511999141447; Email: carolmacruz@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01225001
    • Recruiting
    • Carolina Furtado Macruz
    • Contact: Carolina Macruz; Phone Number: +5511999141447; Email: carolmacruz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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)	Determine the questionnaire scores of quality of life (WHOQOL)	6 months

Collaborators and Investigators

• Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Investigators: Principal Investigator: Black cohosh, Irmandade da Santa Casa Misericordia Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Steroid Synthesis Inhibitors; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen; Exemestane; Aromatase Inhibitors
• Other Study ID Numbers: 349441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: When I have finished my recruitment and analysis of the results.