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Clinical Trials/NCT01543711
NCT01543711
Completed
Not Applicable

Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

Rigshospitalet, Denmark1 site in 1 country2,411 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Rigshospitalet, Denmark
Enrollment
2411
Locations
1
Primary Endpoint
Prevalence of persistent pain
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
April 2012
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth Geving Andersen

MD

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary breast cancer between 2005-2006
  • Participated in a study in 2008

Exclusion Criteria

  • Recurrent or new primary cancer
  • Metastatic cancer
  • Reconstructive surgery

Outcomes

Primary Outcomes

Prevalence of persistent pain

Time Frame: 6-7 years post operative

Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable

Prevalence of patients changing pain status from the 2008 survey

Time Frame: 6-7 years

Secondary Outcomes

  • Prevalence of sensory disturbance(6-7 years)
  • Prevalence of self reported lymphedma(6-7 years)
  • Prevalence of functional impairment(6-7 years)
  • Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment(6-7 years)
  • Prevalence of patients changing status of sensory disturbances and self reported lymphedma(6-7 years)
  • Risk factors associated to changing status of sensory disturbances and lymphedema(6-7 years post operative)

Study Sites (1)

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