N/A
Completed N=178
Sexual Function and Wellbeing in Males With Rectal Cancer
Source: ClinicalTrials.gov NCT01216202 ↗Enrolled (actual)
178
Serious AEs
—
Results posted
Apr 2021
Primary outcomePrimary: Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy. — 11.3; 11.9; 9.3 nmol/L — p=0.014
Summary
Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where measurements of androgen hormone levels, semen samples and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy. |
11.3; 11.9; 9.3 | 0.014 sig |
| PRIMARY Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up. |
164.0; 3.15; 0.0; 32.6 | 0.008 sig |
| PRIMARY Sexual Function |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males diagnosed with rectal cancer stadium I-III, planned for surgery with or without preoperative radiotherapy or males with prostate cancer stadium I-III planned for robot-assisted prostatectomy without preoperative radiotherapy.
- Informed consent
- Fluent in Swedish
- Residents of the Stockholm county area
Exclusion Criteria
- Rectal cancer stadium IV
- Previous radiotherapy to the pelvic region
- History or evidence of a second pelvic malignancy
- Androgen deprivation therapy, Testosterone replacement or Androgen abuse
Data sourced from ClinicalTrials.gov (NCT01216202). 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. Informational only — not medical advice.