Spots Global Cancer Trial Database for Sexual Function and Wellbeing in Females With Rectal Cancer

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Trial Identification

Brief Title: Sexual Function and Wellbeing in Females With Rectal Cancer

Official Title: Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

Study ID: NCT01216189

Conditions

Rectal Cancer

Interventions

Preoperative radiotherapy

Study Description

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.