Rectal CancerNCT01216189
Sexual Function and Wellbeing in Females With Rectal Cancer
An observational study of Rectal Cancer, run by Karolinska Institutet at 5 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Preoperative radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- 5 sitesSweden
- Study dates
- Jun 2008to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females with rectal cancer stadium I-III, planned for abdominal surgery, with or without preoperative radiotherapy.
Who may be able to join
- Females diagnosed with rectal cancer stadium I-III, planned surgery with or without preoperative radiotherapy.
Who cannot join
- Rectal cancer stadium IV
- Previous radiotherapy to the pelvic region
- Inability to provide informed consent.
- Life expectancy less than 2 years.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Linköping University Hospital
Linköping
Norrköping Hospital
Norrköping
Örebro University Hospital
Örebro
Ersta Hospital
Stockholm
Karolinska University Hospital
Stockholm
About this study
Official title: Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Preoperative radiotherapy
- Keywords
- Rectal cancer, Preoperative radiotherapy, Pelvic surgery, Sexual function, Wellbeing, Hormone levels
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative radiotherapy | Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery. Receives: Radiation: Preoperative radiotherapy | |
| No preoperative radiotherapy | Women with rectal cancer treated with surgery alone (no RT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 year after surgery and 2 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJun 2008
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Society
- Responsible party
- Principal investigator, Anna Martling, Karolinska Institutet
- Investigators
- Anna Martling, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216189
- Sponsor's protocol ID
- 2008/247-31/3
- Status last verified
- Apr 2021
- First submitted
- 4 Oct 2010
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23953232Segelman 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.
PubMed 30277569Svanstrom 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.
PubMed 31792944
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer
- ClinicalTrials.gov ID
- NCT01216189
- Acronym / sponsor ID
- 2008/247-31/3
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Preoperative radiotherapy, Pelvic surgery, Sexual function, Wellbeing, Hormone levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Cancer Society
- Study start
- Jun 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 9 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative radiotherapy | – | Radiation: Preoperative radiotherapyWomen with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| No preoperative radiotherapy | – | –Women with rectal cancer treated with surgery alone (no RT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females with rectal cancer stadium I-III, planned for abdominal surgery, with or without preoperative radiotherapy.
Key inclusion criteria (1 listed)
- Females diagnosed with rectal cancer stadium I-III, planned surgery with or without preoperative radiotherapy.
Key exclusion criteria (4 listed)
- Rectal cancer stadium IV
- Previous radiotherapy to the pelvic region
- Inability to provide informed consent.
- Life expectancy less than 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative radiotherapyPreoperative 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. | Radiation | Preoperative radiotherapy |
Primary outcome
Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.
Time frame: Baseline, the week before surgery 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.
Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.
Time frame: Baseline, 1 year after surgery and 2 years after surgery.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23953232Segelman 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.
- Results publication: PubMed 30277569Segelman 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.
- Results publication: PubMed 31792944Svanstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Martling principal investigator
Karolinska Institutet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Karolinska Institutet at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery. (time frame: Baseline, the week before surgery and 1 year after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01216189, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.