SexualityPhase 4CimicifugaNCT02467686
Breast Cancer, Sexuality and Black Cohosh
A Phase 4 study testing WHOQOL questionnaire, FSFI questionnaire and kupperman scale in people with Sexuality, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 48 to 68 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexuality
- What is being tested?
- WHOQOL questionnaire, FSFI questionnaire and kupperman scale
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 68 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor.
- With hot flashes and with or without active sexual life.
Who cannot join
- Women did not have breast cancer
- do not use tamoxifen or aromatase inhibitor
- not in menopause and not have hot flashes
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Carolina Furtado Macruz
São Paulo, São Paulo, 01225001
Carolina Macruz, +5511999141447, carolmacruz@gmail.com
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOQOL questionnaireBehavioural
Also called The World Health Organization Quality of Life
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 questionnaireBehavioural
Also called Female sexual function index (FSFI) questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
kupperman scaleBehavioural
Also called Blatt-Kupperman menopausal index
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Cimicifuga racemosaDrug
Also called Black Cohosh
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
tamoxifenDrug
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
exemestaneDrug
Also called aromatase inhibitor
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: WHOQOL questionnaire; Behavioral: FSFI questionnaire; Behavioral: kupperman scale; Drug: tamoxifen; Drug: exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flashes (score of hot flashes)
Determine the score of hot flashes
Measured: 6 months
Secondary outcomes (2)
Sexual function (score of sexual function questionnaire (FSFI)
Determine the score of sexual function questionnaire (FSFI)
Measured: 3 months
Sexual function (score of sexual function questionnaire (FSFI)
Determine the score of sexual function questionnaire (FSFI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Furtado Macruz, Irmandade da Santa Casa de Misericordia de Sao Paulo
- Investigators
- Black cohosh, Principal investigator, Irmandade da Santa Casa Misericordia Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467686
- Sponsor's protocol ID
- 349441
- Acronym
- Cimicifuga
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2015
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: When I have finished my recruitment and analysis of the results.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cimicifuga Racemosa L. Nutt Sexuality of Women With Breast Cancer Using Tamoxifen or Aromatase Inhibitor
- ClinicalTrials.gov ID
- NCT02467686
- Acronym / sponsor ID
- Cimicifuga / 349441
- Conditions
- Sexuality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao PauloUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cimicifuga racemosa | Active comparator | Behavioral: WHOQOL questionnaire, Behavioral: FSFI questionnaire, Behavioral: kupperman scale, Drug: Cimicifuga racemosa, Drug: tamoxifen, Drug: exemestaneThe 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. |
| Control | Placebo comparator | Behavioral: WHOQOL questionnaire, Behavioral: FSFI questionnaire, Behavioral: kupperman scale, Drug: tamoxifen, Drug: exemestaneControl 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. |
Who may qualify
- Ages
- 48 to 68 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor.
- With hot flashes and with or without active sexual life.
Key exclusion criteria (3 listed)
- Women did not have breast cancer
- do not use tamoxifen or aromatase inhibitor
- not in menopause and not have hot flashes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOQOL questionnaireAlso: The World Health Organization Quality of LifeWHO 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. | Behavioural | Cimicifuga racemosa, Control |
| FSFI questionnaireAlso: Female sexual function index (FSFI) questionnaireFSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up. | Behavioural | Cimicifuga racemosa, Control |
| kupperman scaleAlso: Blatt-Kupperman menopausal indexKupperman scale is a tool to help evaluate the severity of menopausal symptoms | Behavioural | Cimicifuga racemosa, Control |
| Cimicifuga racemosaAlso: Black CohoshThe Cimicifuga racemosa effects on the sexuality of women with Breast cancer | Drug | Cimicifuga racemosa |
| tamoxifenThe Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen | Drug | Cimicifuga racemosa, Control |
| exemestaneAlso: aromatase inhibitorThe Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor. | Drug | Cimicifuga racemosa, Control |
Primary outcome
Hot flashes (score of hot flashes)
Time frame: 6 months
Determine the score of hot flashes
2 secondary outcomes
Sexual function (score of sexual function questionnaire (FSFI)
Time frame: 3 months
Sexual function (score of sexual function questionnaire (FSFI)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: No. When I have finished my recruitment and analysis of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Black cohosh principal investigator
Irmandade da Santa Casa Misericordia Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing WHOQOL questionnaire, FSFI questionnaire and kupperman scale in people with Sexuality, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Macruz (+5511999141447, carolmacruz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot flashes (score of hot flashes) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.