Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
This study is currently recruiting participants.
Verified November 2012 by Rigshospitalet, Denmark
Sponsor:
Rigshospitalet, Denmark
Collaborators:
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01523132
First received: January 27, 2012
Last updated: November 22, 2012
Last verified: November 2012
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| First Received Date ICMJE | January 27, 2012 | ||||||||
| Last Updated Date | November 22, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Risk factors predisposing for persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ] Pre-, intra- and postoperative risk factors predisposing for persistent pain |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01523132 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms | ||||||||
| Official Title ICMJE | Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms | ||||||||
| Brief Summary | The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain. |
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| Detailed Description | The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: blood |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Breast cancer patients treated in a university hospital |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Breast cancer patients
Female breast cancer patients without metastasis and locally advanced disease |
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| Publications * | 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. Epub 2011 Mar 24. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01523132 | ||||||||
| Other Study ID Numbers ICMJE | H-D-2007-0098 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Kenneth Geving Andersen, Rigshospitalet, Denmark | ||||||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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