Clinical trial · Interventional
Breast Cancer, Sexuality and Black Cohosh
Effects of Cimicifuga Racemosa L. Nutt Sexuality of Women With Breast Cancer Using Tamoxifen or Aromatase Inhibitor
NCT02467686CI-TRIAL-00026519CimicifugaunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sexuality | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cimicifuga racemosa | Drug | — | UNRESOLVED |
| exemestane | Drug | Exemestane | ALIAS |
| FSFI questionnaire | Behavioral | — | UNRESOLVED |
| kupperman scale | Behavioral | — | UNRESOLVED |
| tamoxifen | Drug | Tamoxifen | ALIAS |
| WHOQOL questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cimicifuga racemosa
- description
- 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.
- interventionNames
- Behavioral: WHOQOL questionnaire
- Behavioral: FSFI questionnaire
- Behavioral: kupperman scale
- Drug: Cimicifuga racemosa
- Drug: tamoxifen
- Drug: exemestane
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 48 Years
- Maximum age
- 68 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.