Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

This study is ongoing, but not recruiting participants.
Sponsor:
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: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition
Breast Cancer
Persistent Pain
Lymphedema
Neuropathic Pain
Neuropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Prevalence of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
  • Prevalence of sensory disturbances after breast cancer treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Genetic markers and the development of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
  • QST profile 1 week after surgery for breast cancer [ Time Frame: 1 week postoperative ] [ Designated as safety issue: No ]
    Detailed QST profile 1 week after surgery for breast cancer. Patients will be assessed with sensory mapping, followed by assessment of mechanical and thermal thresholds.

  • Acute pain after surgery for breast cancer [ Time Frame: 1 week postoperative ] [ Designated as safety issue: No ]
    Prevalence of acute pain 1 week after surgery for breast cancer.

  • Test-Retest of QST after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
    A test-retest series of a subgroup of patients assessed with QST, to evaluate methodological reliability. Patients are scheduled to 2 QST assessments with a week between.


Biospecimen Retention:   Samples With DNA

blood


Enrollment: 545
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer patients
Female breast cancer patients without metastasis and locally advanced disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer patients treated in a university hospital

Criteria

Inclusion Criteria:

  • Diagnosed with breast cancer
  • 18 years or older

Exclusion Criteria:

  • unable to give written consent
  • unable to understand Danish
  • Previous cosmetic surgery in the breast
  • Previous surgery in ipsilateral breast
  • Bilateral cancer
  • Concomitant corrective surgery on contralateral side
  • Pregnant
  • Other disease or injury in the nervous system
  • Psychiatric disease
  • Alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523132

Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Investigators
Principal Investigator: Kenneth Geving Andersen, MD Rigshospitalet, Denmark
Study Chair: Henrik Kehlet, MD, PhD Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Kenneth Geving Andersen, Physician, research fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01523132     History of Changes
Other Study ID Numbers: H-D-2007-0098
Study First Received: January 27, 2012
Last Updated: August 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neuralgia
Breast Diseases
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014