Sexual Function and Wellbeing in Females With Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Radiation: Preoperative radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative radiotherapy<br>Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. | Radiation: Preoperative radiotherapy<br>* Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.<br>|
| No preoperative radiotherapy<br>Women with rectal cancer treated with surgery alone (no RT). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Preoperative radiotherapy, Pelvic surgery, Sexual function, Wellbeing, Hormone levels