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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543711
• Other study ID #: 2007-41-1530
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: June 5, 2013
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: June 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2411
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Neuropathy
• Pain
• Pain, Postoperative
• Post Operative Pain

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of persistent pain	Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable	6-7 years post operative	No
Primary	Prevalence of patients changing pain status from the 2008 survey		6-7 years	No
Secondary	Prevalence of sensory disturbance		6-7 years	No
Secondary	Prevalence of self reported lymphedma		6-7 years	No
Secondary	Prevalence of functional impairment		6-7 years	No
Secondary	Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment		6-7 years	No
Secondary	Prevalence of patients changing status of sensory disturbances and self reported lymphedma		6-7 years	No
Secondary	Risk factors associated to changing status of sensory disturbances and lymphedema		6-7 years post operative	No