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Sexual Function and Wellbeing in Males Diagnosed With Rectal Cancer

This study is currently recruiting participants.
Verified February 2013 by Karolinska Institutet
Sponsor:
Collaborator:
Swedish Cancer Society
Information provided by (Responsible Party):
Anna Martling, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01216202
First received: October 4, 2010
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Sexual function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hormone levels [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216202

Contacts
Contact: Anna Martling, M.D Ph.D +46851772802 anna.martling@karolinska.se

Locations
Sweden
Gastrocentrum kirurgi, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Anna Martling, M.D Ph.D     +46851772802        
Sponsors and Collaborators
Karolinska Institutet
Swedish Cancer Society
  More Information

No publications provided

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
Study First Received: October 4, 2010
Last Updated: February 8, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Rectal cancer
Preoperative radiotherapy
Pelvic surgery
Sexual function
 Wellbeing
Hormone levels
Spermatogenesis

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

ClinicalTrials.gov processed this record on May 19, 2013