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Sexual Function and Wellbeing in Females With Rectal Cancer

Karolinska Institute logo

Karolinska Institute

Status

Completed

Conditions

Rectal Cancer

Treatments

Radiation: Preoperative radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT01216189
2008/247-31/3

Details and patient eligibility

About

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.

Full 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.

Enrollment

142 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

142 participants in 2 patient groups

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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