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Completed

NCT Number: NCT01543711

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathy Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Post Operative Pain Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Prevalence of patients changing pain status from the 2008 survey

    Time frame: 6-7 years

Secondary outcomes

  1. Prevalence of sensory disturbance

    Time frame: 6-7 years

  2. Prevalence of self reported lymphedma

    Time frame: 6-7 years

  3. Prevalence of functional impairment

    Time frame: 6-7 years

  4. Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment

    Time frame: 6-7 years

  5. Prevalence of patients changing status of sensory disturbances and self reported lymphedma

    Time frame: 6-7 years

  6. Risk factors associated to changing status of sensory disturbances and lymphedema

    Time frame: 6-7 years post operative

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Cancer Society

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2012
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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