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| Name | Class |
|---|---|
| Swedish Cancer Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative radiotherapy | Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| |
| No preoperative radiotherapy | Women with rectal cancer treated with surgery alone (no RT). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative radiotherapy | Radiation | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Females with rectal cancer stadium I-III, planned for abdominal surgery, with or without preoperative radiotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Martling | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University Hospital | Linköping | Sweden | ||||
| Norrköping Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23953232 | Background | 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. | |
| 30277569 | Result | 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. |
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Participants were recruited from five Swedish outpatient rectal cancer centres in Sweden (Karolinska University Hospital, Ersta Hospital, Örebro University Hospital, Linköping University Hospital and Norrköping Hospital) between June 2008 and August 2013. Of 404 women with rectal cancer assessed for eligibility, 142 were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Radiotherapy | Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| FG001 | No Preoperative Radiotherapy | Women with rectal cancer treated with surgery alone (no RT). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Radiotherapy | Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| BG001 | No Preoperative Radiotherapy | Women with rectal cancer treated with surgery alone (no RT). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 17 of the included 142 participants were excluded due to history of oophorectomy, resulting in 125 participants analysed. Participants in the group "No preoperative radiotherapy" had no blood samples taken at the time point "After RT/before surgery". | Posted | Median | Full Range | nmol/l | Baseline, the week before surgery and 1 year after surgery. |
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Adverse Events were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preoperative RT | Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Anna Martling | Karolinska Institutet | +46851770000 | anna.martling@ki.se |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Venous blood samples.
|
| Norrköping |
| Sweden |
| Örebro University Hospital | Örebro | Sweden |
| Ersta Hospital | Stockholm | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| 31792944 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Median | Full Range | kg/m2 |
|
| ASA score | ASA score is a classification system for physical status ranging from scores I to VI with higher scores indicating worse physical status. Definitions of scores: I = Normal healthy person, II = A patient with mild systemic disease, III = A patient with severe systemic disease. | Count of Participants | Participants |
|
| Tumour distance from anal verge | Count of Participants | Participants |
|
| Type of preoperative RT | Count of Participants | Participants |
|
| Type of Surgery | Count of Participants | Participants |
|
| Resection of gynaecological organs | Includes resections before study inclusion and as part of rectal cancer surgery. | Count of Participants | Participants |
|
| Pathological tumour stage | Pathological tumour stage is determined by examining tissue removed during surgery. Staging is based on the American Joint Committee on Cancer (AJCC) TNM system, with T being the extent of the tumour, N spread to nearby lymph nodes and M spread to distant sites. This is summarised into a score ranging from 0 to IV, with 0 being very early cancer and higher numbers indicating more advanced cancer. | Count of Participants | Participants |
|
| Neoadjuvant chemotherapy | Count of Participants | Participants |
|
| Adjuvant chemotherapy | Count of Participants | Participants |
|
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| OG001 | No Preoperative Radiotherapy | Women with rectal cancer treated with surgery alone (no RT). |
|
|
|
| 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. | Of the 142 participants included in the study, 3 were excluded due to not answering FSFI questionnaires at any timepoint. Total FSFI scores were only calculated for available questionnaires without missing items. | Posted | Median | Full Range | score on a scale | Baseline, 1 year after surgery and 2 years after surgery. |
|
|
|
|
| 4 |
| 110 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Preoperative RT | Women with rectal cancer treated with surgery alone (no RT). | 2 | 32 | 0 | 0 | 0 | 0 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| 1 year after surgery |
|
|
| 2 years after surgery |
|
|