Persistent Pain After Reconstruction Following Mastectomy

This study has been completed.
Sponsor:
Collaborator:
Danish Breast Cancer Cooperative Group
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01738048
First received: November 22, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.


Condition Intervention
Breast Cancer
Chronic Pain
Procedure: Reconstruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Persistent Pain After Reconstruction Following Mastectomy

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The risk of developing persistent if reconstructed [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ] [ Designated as safety issue: No ]
    The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.


Secondary Outcome Measures:
  • Prevalence of persistent pain after reconstruction after mastectomy [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ] [ Designated as safety issue: No ]
    Self reported pain expressed as a percentage of the population of patients reconstructed with expander and autologous tissue. Pain intensity measured with a numerical rating scale 0-10, divided in mild (NRS 1-3), moderate (4-6) and severe pain (7-10). Patients regarded as having clinically relevant pain: NRS 4 or above, at least at a weekly basis.

  • Prevalence of sensory disturbances after reconstruction after mastectomy [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ] [ Designated as safety issue: No ]

Enrollment: 1352
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mastectomy
Patients treated with mastectomy without reconstruction
Reconstruction
Patients treated with mastectomy followed by reconstruction
Procedure: Reconstruction
Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction

Detailed Description:

The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Nationwide cross-sectional cohort

Criteria

Inclusion Criteria:

  • Patients with unilateral primary breast cancer aged 18-70 years

Exclusion Criteria:

  • recurrent cancer
  • other malignancy
  • emigration
  • non-standardized treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738048

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Breast Cancer Cooperative Group
Investigators
Principal Investigator: Kenneth G Andersen, MD Rigshospitalet, University of Copenhagen
  More Information

Publications:
Responsible Party: Kenneth Geving Andersen, Physician, research fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01738048     History of Changes
Other Study ID Numbers: H-D-2007-0099B
Study First Received: November 22, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Pain
Neuropathic pain
Chronic pain

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014