Sexual Function and Wellbeing in Females With Rectal Cancer

April 8, 2021 updated by: Anna Martling, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden
        • Linkoping University Hospital
      • Norrköping, Sweden
        • Norrköping Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Stockholm, Sweden
        • Ersta Hospital
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preoperative radiotherapy
Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
Radiation: Preoperative radiotherapy
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.
No preoperative radiotherapy
Women with rectal cancer treated with surgery alone (no RT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, the week before surgery and 1 year after surgery.
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.
Baseline, 1 year after surgery and 2 years after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Swedish Cancer Society

Investigators

  • Principal Investigator: Anna Martling, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/247-31/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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