Clinical trial NCT01216189: Sexual Function and Wellbeing in Females With Rectal Cancer
Official title: Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal cancer
Preoperative radiotherapy
Pelvic surgery
Sexual function
Wellbeing
Hormone levels
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Society
First posted: 2010-10-07
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females with rectal cancer stadium I-III, planned for abdominal surgery, with or without preoperative radiotherapy.

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.

Eligibility criteria: Inclusion Criteria:

* Females diagnosed with rectal cancer stadium I-III, planned surgery with or without preoperative radiotherapy.

Exclusion Criteria:

* Rectal cancer stadium IV
* Previous radiotherapy to the pelvic region
* Inability to provide informed consent.
* Life expectancy less than 2 years.

Primary outcomes:
measure: Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.
timeFrame: Baseline, the week before surgery and 1 year after surgery.
measure: Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.
timeFrame: Baseline, 1 year after surgery and 2 years after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Norrköping
country: Sweden
facility: Norrköping Hospital
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anna Martling
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segelman J, Martling A, Machado M, Holm T, Bergmark K, Floter Radestad A. Preoperative sexual function in women with rectal cancer. Eur J Surg Oncol. 2013 Oct;39(10):1079-86. doi: 10.1016/j.ejso.2013.07.091. Epub 2013 Aug 15.
citation: Segelman J, Buchli C, Svanstrom Rojvall A, Matthiessen P, Arver S, Bottai M, Ahlberg M, Jasuja R, Floter-Radestad A, Martling A. Effect of radiotherapy for rectal cancer on ovarian androgen production. Br J Surg. 2019 Feb;106(3):267-275. doi: 10.1002/bjs.10980. Epub 2018 Sep 12.
citation: Svanstrom Rojvall A, Buchli C, Bottai M, Ahlberg M, Floter-Radestad A, Martling A, Segelman J. Effect of radiotherapy for rectal cancer on female sexual function: a prospective cohort study. Br J Surg. 2020 Apr;107(5):525-536. doi: 10.1002/bjs.11373. Epub 2019 Dec 3.