Sexual Function and Wellbeing in Females With Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Radiation: Preoperative radiotherapy
- Registration Number
- NCT01216189
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Preoperative radiotherapy (RT) and pelvic surgery is recommended to many patients with rectal cancer. For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.
- Detailed Description
Women with rectal cancer stage I to III planned for abdominal surgery was included in the study. Women treated with preoperative RT were assigned to the exposed group and women treated with surgery alone were assigned to the unexposed group.
142 participants were enrolled at five outpatient rectal cancer centres in Sweden between 2008 and 2013. Patient data, fasting venous blood samples and questionnaires regarding sexual function and well-being were collected at a baseline visit before start of oncologic treatment, 1 year after surgery and 2 years after surgery (only questionnaires). Women treated with preoperative RT for rectal cancer had an additional venous blood sample taken the day before surgery.
Changes in serum levels of testosterone and sexual function during follow-up was assessed and compared between exposed and unexposed participants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 142
- Females diagnosed with rectal cancer stadium I-III, planned surgery with or without preoperative radiotherapy.
- Rectal cancer stadium IV
- Previous radiotherapy to the pelvic region
- Inability to provide informed consent.
- Life expectancy less than 2 years.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Preoperative radiotherapy Preoperative radiotherapy Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
- Primary Outcome Measures
Name Time Method Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery. Baseline, the week before surgery and 1 year after surgery. Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.
Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up. Baseline, 1 year after surgery and 2 years after surgery. Sexual function was assessed using the Female Sexual Function Index (FSFI). The FSFI questionnaire is a 19-item multiple-choice, self-assessment tool validated for use in the general population as well as for patients with cancer. It covers six domains of sexual function in women; desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). Items scores between 0 or 1 to 5, with lower scores indicating worse function. A total FSFI score can be calculated when all items are completed. Minimal total score is 4 points and maximal score is 95 points, with lower scores indicating worse function. A total FSFI score of less than 26.55 points was used to define overall sexual dysfunction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Linköping University Hospital
🇸🇪Linköping, Sweden
Norrköping Hospital
🇸🇪Norrköping, Sweden
Ersta Hospital
🇸🇪Stockholm, Sweden
Örebro University Hospital
🇸🇪Örebro, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden