Sexuality
Conditions
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.
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.
Interventions
BEHAVIORALWHOQOL 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.
BEHAVIORALFSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
BEHAVIORALkupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
DRUGtamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
DRUGexemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
Sponsors
Irmandade da Santa Casa de Misericordia de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
48 Years to 68 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot flashes (score of hot flashes) | 6 months | Determine the score of hot flashes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function (score of sexual function questionnaire (FSFI) | 3 months | Determine the score of sexual function questionnaire (FSFI) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (questionnaire scores of quality of life (WHOQOL) | 3 months | Determine the questionnaire scores of quality of life (WHOQOL) |
Countries
Brazil
Contacts
Primary ContactCarolina Macruz
Outcome results
None listed