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Sexual Function and Wellbeing in Males Diagnosed With Rectal Cancer

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ClinicalTrials.gov Identifier: NCT01216202
Recruitment Status : Active, not recruiting
First Posted : October 7, 2010
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease
Rectal Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Sexual function [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Hormone levels [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men with rectal cancer stadium I-III, planned for abdominal surgery with or without preoperative radiotherapy.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216202

Gastrocentrum kirurgi, Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Cancer Society
More Information

Responsible Party: Anna Martling, Associate Professor, Senior Consultant Surgeon, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01216202     History of Changes
Other Study ID Numbers: 2009/1860-31/2
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Anna Martling, Karolinska Institutet:
Rectal cancer
Preoperative radiotherapy
Pelvic surgery
Sexual function
Hormone levels

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases