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Breast Cancer, Sexuality and Black Cohosh (Cimicifuga)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467686
Recruitment Status : Unknown
Verified March 2017 by Carolina Furtado Macruz, Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 10, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Carolina Furtado Macruz, Irmandade da Santa Casa de Misericordia de Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sexuality Behavioral: WHOQOL questionnaire Behavioral: FSFI questionnaire Behavioral: kupperman scale Drug: Cimicifuga racemosa Drug: tamoxifen Drug: exemestane Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Cimicifuga Racemosa L. Nutt Sexuality of Women With Breast Cancer Using Tamoxifen or Aromatase Inhibitor
Study Start Date : January 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Female sexual function index (FSFI) questionnaire

Behavioral: kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Other Name: Blatt-Kupperman menopausal index

Drug: Cimicifuga racemosa
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
Other Name: 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 Name: 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 Name: 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 Name: Female sexual function index (FSFI) questionnaire

Behavioral: kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Other Name: 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 Name: aromatase inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Hot flashes (score of hot flashes) [ Time Frame: 6 months ]
    Determine the score of hot flashes


Secondary Outcome Measures :
  1. Sexual function (score of sexual function questionnaire (FSFI) [ Time Frame: 3 months ]
    Determine the score of sexual function questionnaire (FSFI)

  2. Sexual function (score of sexual function questionnaire (FSFI) [ Time Frame: 6 months ]
    Determine the score of sexual function questionnaire (FSFI)


Other Outcome Measures:
  1. Quality of life (questionnaire scores of quality of life (WHOQOL) [ Time Frame: 3 months ]
    Determine the questionnaire scores of quality of life (WHOQOL)

  2. Quality of life (questionnaire scores of quality of life (WHOQOL) [ Time Frame: 6 months ]
    Determine the questionnaire scores of quality of life (WHOQOL)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   48 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467686


Contacts
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Contact: Carolina Macruz +5511999141447 carolmacruz@gmail.com

Locations
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Brazil
Carolina Furtado Macruz Recruiting
Sao Paulo, Brazil, 01225001
Contact: Carolina Macruz    +5511999141447    carolmacruz@gmail.com   
Sponsors and Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
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Principal Investigator: Black cohosh Irmandade da Santa Casa Misericordia Sao Paulo
More Information
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Responsible Party: Carolina Furtado Macruz, Doctor, Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier: NCT02467686    
Other Study ID Numbers: 349441
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: When I have finished my recruitment and analysis of the results.
Additional relevant MeSH terms:
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Tamoxifen
Exemestane
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action