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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01216189
Study type Observational
Source Karolinska Institutet
Contact
Status Completed
Phase
Start date June 2008
Completion date December 2015

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