Breast Cancer, Sexuality and Black Cohosh

NCT02467686 | Unknown Phase 4

• 1 other identifier: 349441
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexuality

Outcome Measures

Primary Outcomes (1)

• Hot flashes (score of hot flashes)

  Determine the score of hot flashes

  6 months

Secondary Outcomes (2)

• Sexual function (score of sexual function questionnaire (FSFI)

  3 months

• Sexual function (score of sexual function questionnaire (FSFI)

  6 months

Other Outcomes (2)

• Quality of life (questionnaire scores of quality of life (WHOQOL)

  3 months

• Quality of life (questionnaire scores of quality of life (WHOQOL)

  6 months

Study Arms (2)

Cimicifuga racemosa

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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; Behavioral: FSFI questionnaire; Behavioral: kupperman scale; Drug: tamoxifen; Drug: exemestane

Interventions

WHOQOL questionnaire BEHAVIORAL

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.

Also known as: The World Health Organization Quality of Life

Cimicifuga racemosa; Control

FSFI questionnaire BEHAVIORAL

FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.

Also known as: Female sexual function index (FSFI) questionnaire

Cimicifuga racemosa; Control

kupperman scale BEHAVIORAL

Kupperman scale is a tool to help evaluate the severity of menopausal symptoms

Also known as: Blatt-Kupperman menopausal index

Cimicifuga racemosa; Control

Cimicifuga racemosa DRUG

The Cimicifuga racemosa effects on the sexuality of women with Breast cancer

Also known as: Black Cohosh

Cimicifuga racemosa

tamoxifen DRUG

The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen

Cimicifuga racemosa; Control

exemestane DRUG

The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.

Also known as: aromatase inhibitor

Cimicifuga racemosa; Control

Eligibility Criteria

• Age: 48 Years - 68 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor.
• With hot flashes and with or without active sexual life.

You may not qualify if:

• Women did not have breast cancer
• do not use tamoxifen or aromatase inhibitor
• not in menopause and not have hot flashes

Sponsors & Collaborators

• Irmandade da Santa Casa de Misericordia de Sao Paulo: lead

Study Sites (1)

Carolina Furtado Macruz

São Paulo, São Paulo, 01225001, Brazil

RECRUITING

MeSH Terms

Conditions

Sexuality

Interventions

Surveys and Questionnaires; black cohosh root extract; Tamoxifen; exemestane; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Black cohosh

  Irmandade da Santa Casa Misericordia Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Macruz

CONTACT

+5511999141447; carolmacruz@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: June 10, 2015
• Study Start: January 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)