Sexual Function and Wellbeing in Males With Rectal Cancer

Karolinska Institute

Status: Completed

Conditions: Rectal Cancer

Treatments: Radiation: Preoperative radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT01216202

2009/1860-31/2

Details and patient eligibility

About

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.

Full description

Men with rectal cancer stage I to III planned for resection was included in the study. Men treated with preoperative RT were assigned to the exposed group and men treated with surgery alone were assigned to the unexposed group. Eighteen months after start of inclusion, less than 10% of the participants were treated with surgery alone. To increase the sample size of the unexposed group, men with prostate cancer stage I to III and scheduled for robot-assisted prostatectomy were also included.

Participants with rectal cancer were enrolled at two centres in Stockholm (Karolinska University Hospital and Ersta Hospital) between 2010 and 2014. Participants with prostate cancer were enrolled at the Urology department of the Karolinska University Hospital in Stockholm between 2012 and 2013.

Patient data, fasting venous blood samples, semen samples and questionnaires regarding sexual function and well being were collected before start of oncological treatment (baseline), 1 and 2 years after surgery. Men treated with preoperative RT for rectal cancer had an additional venous blood sample during the week before surgery. Men with rectal cancer under 55 years of age were offered semen cryopreservation.

Participants could choose if they wanted to participate in one, two or three of the following parts; hormone analysis, semen analysis and/ or questionnaires regarding sexual function and well being. Semen sampling and cryopreservation was not performed in men with prostate cancer.

Changes in hormone levels, semen measurements and sexual function during follow-up were assessed, and compared between exposed and unexposed participants.

Enrollment: 178 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

178 participants in 2 patient groups

Preoperative RT

Description:

Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.

Treatment:

Radiation: Preoperative radiotherapy

No preoperative RT

Description:

Men with rectal cancer or prostate cancer treated with surgery alone (no RT).