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Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216189
First Posted: October 7, 2010
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swedish Cancer Society
Information provided by (Responsible Party):
Anna Martling, Karolinska Institutet
  Purpose
Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer.For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where patients, before preoperative radiotherapy and one year after surgery, take blood tests and answer two questionnaires.

Condition
Rectal Cancer

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

Further study details as provided by Anna Martling, Karolinska Institutet:

Secondary Outcome Measures:
  • Hormone levels [ Time Frame: 2 year ]

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

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:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Females with rectal cancer stadium I-III, planned for abdominal surgery, with or without preoperative radiotherapy.
Criteria

Inclusion Criteria:

  • Females diagnosed with rectal cancer stadium I-III, planned 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): NCT01216189


Locations
Sweden
Ersta Hospital
Stockholm, Sweden
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: NCT01216189     History of Changes
Other Study ID Numbers: 2008/247-31/3
First Submitted: October 4, 2010
First Posted: October 7, 2010
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
Wellbeing
Hormone levels

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