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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: April 2012

Arms, Groups and Cohorts

  • Breast cancer survivors
    • Women treated for breast cancer, without signs of recurrence or metastasis

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • Danish Cancer Society
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kenneth Geving Andersen, MD – Rigshospitalet, Denmark
  • Overall Official(s)
    • Kenneth Geving Andersen, MD, Principal Investigator, Rigshospitalet, Denmark

References

Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24. Review.

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