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

This study has been completed.
Danish Cancer Society
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark Identifier:
First received: February 28, 2012
Last updated: June 5, 2013
Last verified: June 2013
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.

Breast Cancer
Post Operative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Prevalence of sensory disturbance [ Time Frame: 6-7 years ]
  • Prevalence of self reported lymphedma [ Time Frame: 6-7 years ]
  • Prevalence of functional impairment [ Time Frame: 6-7 years ]
  • Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment [ Time Frame: 6-7 years ]
  • Prevalence of patients changing status of sensory disturbances and self reported lymphedma [ Time Frame: 6-7 years ]
  • Risk factors associated to changing status of sensory disturbances and lymphedema [ Time Frame: 6-7 years post operative ]

Enrollment: 2411
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Breast cancer survivors
Women treated for breast cancer, without signs of recurrence or metastasis


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008

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
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Please refer to this study by its identifier: NCT01543711

Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Cancer Society
Principal Investigator: Kenneth Geving Andersen, MD Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kenneth Geving Andersen, MD, Rigshospitalet, Denmark Identifier: NCT01543711     History of Changes
Other Study ID Numbers: 2007-41-1530
Study First Received: February 28, 2012
Last Updated: June 5, 2013

Keywords provided by Rigshospitalet, Denmark:
Breast cancer
persistent pain
neuropathic pain

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms processed this record on May 22, 2017