Sexuo-physiological functioning after cervical cancer treatment
- Registration Number
- NL-OMON25666
- Lead Sponsor
- eiden University Medical Center (LUMC), Leiden, The Netherlands.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Eligible women are: treated for early stage cervical cancer (FIGO IA2 – IIA) at least 12 months before; treated with conventional radical hysterectomy with pelvic lymphadenectomy using the Okabayashi method (RHL-WO) at the AMC; younger than 52 years old; pre-menopausal; and have a performance status of WHO 1-2 and Karnofsky >60. Women are selected on menopausal status, because this can have influence on the vaginal perfusion response. In case eligible women of 40-52 years old that menstruated regularly before the RHL-WO, and report menopausal complaints, LH and FSH-values are measured by taking a blood sample so that their menopausal status could be established.
Exclusion criteria are: signs of recurrent or metastatic cervical cancer after 1 year; treatment with external beam radiation therapy, intravaginal brachytherapy and/or concomitant chemotherapy; removed ovaries during surgery; not being able to understand, read and write the Dutch language; and being pregnant. Use of medication and hormonal substitutes is registered.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method