Rectal Cancer Clinical Trial
Official title:
Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer
NCT number | NCT01216189 |
Other study ID # | 2008/247-31/3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2008 |
Est. completion date | December 2015 |
Verified date | April 2021 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 142 |
Est. completion date | December 2015 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Linköping University Hospital | Linköping | |
Sweden | Norrköping Hospital | Norrköping | |
Sweden | Örebro University Hospital | Örebro | |
Sweden | Ersta Hospital | Stockholm | |
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Swedish Cancer Society |
Sweden,
Segelman J, Buchli C, Svanström Röjvall A, Matthiessen P, Arver S, Bottai M, Ahlberg M, Jasuja R, Flöter-Rådestad 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. — View Citation
Segelman J, Martling A, Machado M, Holm T, Bergmark K, Flöter Rådestad 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. — View Citation
Svanström Röjvall A, Buchli C, Bottai M, Ahlberg M, Flöter-Rådestad 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Serum Testosterone Levels Between Baseline 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. | Baseline, the week before surgery and 1 year after surgery. | |
Primary | Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up. | 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. | Baseline, 1 year after surgery and 2 years after surgery. |
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