This trial is active, not recruiting.

Condition rectal cancer
Sponsor Karolinska Institutet
Collaborator Swedish Cancer Society
Start date April 2010
End date December 2016
Trial size 100 participants
Trial identifier NCT01216202, 2009/1860-31/2


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 patients can choose to take part in one, two or three parts of the study. The three different parts are blood tests, questionnaires and semen samples.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Sexual function
time frame: 2 years

Secondary Outcomes

Hormone levels
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Males diagnosed with rectal cancer stadium I-III, planned for surgery with or without preoperative radiotherapy Exclusion Criteria: - Rectal cancer stadium IV - Previous radiotherapy to the pelvic region

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.