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

NCT ID: NCT01543711

Last Updated: 2013-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Pain Post Operative Pain Lymphedema Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Breast cancer survivors

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Geving Andersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Geving Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Gartner 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.

Reference Type BACKGROUND
PMID: 19903919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21435953 (View on PubMed)

Mejdahl MK, Andersen KG, Gartner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865.

Reference Type DERIVED
PMID: 23580693 (View on PubMed)

Other Identifiers

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2007-41-1530

Identifier Type: -

Identifier Source: org_study_id

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