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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01543711
First received: February 28, 2012
Last updated: March 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer
Pain
Post Operative Pain
Lymphedema
Neuropathy

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:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Prevalence of persistent pain [ Time Frame: 6-7 years post operative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of sensory disturbance [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Prevalence of self reported lymphedma [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Prevalence of functional impairment [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Prevalence of patients changing status of sensory disturbances and self reported lymphedma [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Risk factors associated to changing status of sensory disturbances and lymphedema [ Time Frame: 6-7 years post operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 2828
Study Start Date: January 2012
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer survivors
Women treated for breast cancer, without signs of recurrence or metastasis

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543711

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

Publications:

Responsible Party: Kenneth Geving Andersen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01543711     History of Changes
Other Study ID Numbers: 2007-41-1530
Study First Received: February 28, 2012
Last Updated: March 2, 2012
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Pain, Postoperative
Sensation Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Lymphatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2012