N/A
N=142
Sexual Function and Wellbeing in Females With Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01216189 ↗Enrolled (actual)
142
Serious AEs
—
Results posted
Apr 2021
Primary outcome: Primary: Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery. — 0.6; 0.6; 0.6; 0.5 nmol/l — p=0.004
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Preoperative radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Karolinska Institutet
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery. |
0.6; 0.6; 0.6; 0.5; 0.6 | 0.004 sig |
| PRIMARY Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up. |
18.5; 6.7; 11.1; 5.8; 10.8; 6.5 | 0.013 sig |
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. 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01216189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.