Sexual Function and Wellbeing in Males With Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Sexual Function and Wellbeing in Males Diagnosed With Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216202
• Other study ID #: 2009/1860-31/2
• Status: Completed
• Start date: April 2010
• Est. completion date: May 2016

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: May 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Preoperative radiotherapy
Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference. Testicular doses (TDs) was calculated from planning CT-scans and reported as mean cumulative testicular dose. Relative TD was calculated based in the assumption that RT regimens for rectal cancer are bioequivalent and referred to as proportion of prescribed dose absorbed by the testes.

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Buchli C, Al Abani M, Ahlberg M, Holm T, Fokstuen T, Bottai M, Frodin JE, Lax I, Martling A. Assessment of testicular dose during preoperative radiotherapy for rectal cancer. Acta Oncol. 2016;55(4):496-501. doi: 10.3109/0284186X.2015.1073349. Epub 2015 Sep 11. — View Citation

Buchli C, Martling A, Abani MA, Frodin JE, Bottai M, Lax I, Arver S, Holm T. Risk of Acute Testicular Failure After Preoperative Radiotherapy for Rectal Cancer: A Prospective Cohort Study. Ann Surg. 2018 Feb;267(2):326-331. doi: 10.1097/SLA.00000000000020 — View Citation

Buchli C, Tapper J, Bottai M, Holm T, Arver S, Blomqvist L, Martling A. Testosterone and body composition in men after treatment for rectal cancer. J Sex Med. 2015 Mar;12(3):774-82. doi: 10.1111/jsm.12751. Epub 2014 Nov 12. — View Citation

Tapper J, Arver S, Holm T, Bottai M, Machado M, Jasuja R, Martling A, Buchli C. Acute primary testicular failure due to radiotherapy increases risk of severe postoperative adverse events in rectal cancer patients. Eur J Surg Oncol. 2020 Jan;46(1):98-104. doi: 10.1016/j.ejso.2019.07.023. Epub 2019 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy.	Fasting morning venous blood samples were collected at baseline, eg prior to oncological treatment. Men with rectal cancer treated with preoperative radiotherapy (RT) had a second blood sample taken afte RT and before surgery, collected the week before surgery and defined as "after RT/before surgery". Elapsed time between start of RT and the second blood sample was median 38 days, ranging from 3 to 195 days depending on the type of preoperative oncological treatment regimen. Testosterone (T) was analysed at the Department of Clinical Chemistry, Karolinska University Hospital, using commercial assays.	Baseline and after RT/before surgery.
Primary	Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up.	Semen samples were collected at the Department of Reproductive Medicine of Karolinska University Hospital after 72h of sexual abstinence and analysed according to World Health Organization 2010 standard. Total number of sperms (million spermatozoa per ejaculate), was calculated by multiplying sperm concentration (million spermatozoa per millilitre semen) with semen volume (milliliter semen/ejaculate). Total number of sperms below 39 million per ejaculate was defined as oligospermia, and 0 million per ejaculate was defined as azoospermia. Semen samples were only collected in men with rectal cancer, not prostate cancer.	Baseline, 1 and 2 years after surgery.
Primary	Sexual Function		2 years