Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 2:58 PM
Study NCT ID:
NCT01523132
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk factors predisposing for persistent pain after breast cancer treatment', 'timeFrame': '12 months postoperative', 'description': 'Pre-, intra- and postoperative risk factors predisposing for persistent pain'}], 'secondaryOutcomes': [{'measure': 'Prevalence of persistent pain after breast cancer treatment', 'timeFrame': '12 months postoperative'}, {'measure': 'Prevalence of sensory disturbances after breast cancer treatment', 'timeFrame': '12 months'}, {'measure': 'Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve', 'timeFrame': '12 months'}, {'measure': 'Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors', 'timeFrame': '12 months'}, {'measure': 'Genetic markers and the development of persistent pain after breast cancer treatment', 'timeFrame': '12 months postoperative'}, {'measure': 'QST profile 1 week after surgery for breast cancer', 'timeFrame': '1 week postoperative', 'description': '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.'}, {'measure': 'Acute pain after surgery for breast cancer', 'timeFrame': '1 week postoperative', 'description': 'Prevalence of acute pain 1 week after surgery for breast cancer.'}, {'measure': 'Test-Retest of QST after breast cancer treatment', 'timeFrame': '12 months postoperative', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Persistent Pain', 'Lymphedema', 'Neuropathic Pain', 'Neuropathy']}, 'referencesModule': {'references': [{'pmid': '21435953', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26176893', 'type': 'RESULT', 'citation': 'Andersen KG, Duriaud HM, Jensen HE, Kroman N, Kehlet H. Predictive factors for the development of persistent pain after breast cancer surgery. Pain. 2015 Dec;156(12):2413-2422. doi: 10.1097/j.pain.0000000000000298.'}, {'pmid': '25084072', 'type': 'RESULT', 'citation': 'Andersen KG, Kehlet H, Aasvang EK. Test-retest agreement and reliability of quantitative sensory testing 1 year after breast cancer surgery. Clin J Pain. 2015 May;31(5):393-403. doi: 10.1097/AJP.0000000000000136.'}, {'pmid': '26446738', 'type': 'RESULT', 'citation': 'Andersen KG, Duriaud HM, Aasvang EK, Kehlet H. Association between sensory dysfunction and pain 1 week after breast cancer surgery: a psychophysical study. Acta Anaesthesiol Scand. 2016 Feb;60(2):259-69. doi: 10.1111/aas.12641. Epub 2015 Oct 8.'}, {'pmid': '25307709', 'type': 'RESULT', 'citation': 'Andersen KG, Aasvang EK, Kroman N, Kehlet H. Intercostobrachial nerve handling and pain after axillary lymph node dissection for breast cancer. Acta Anaesthesiol Scand. 2014 Nov;58(10):1240-8. doi: 10.1111/aas.12393.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients treated in a university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with breast cancer\n* 18 years or older\n\nExclusion Criteria:\n\n* unable to give written consent\n* unable to understand Danish\n* Previous cosmetic surgery in the breast\n* Previous surgery in ipsilateral breast\n* Bilateral cancer\n* Concomitant corrective surgery on contralateral side\n* Pregnant\n* Other disease or injury in the nervous system\n* Psychiatric disease\n* Alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01523132', 'briefTitle': 'Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms', 'orgStudyIdInfo': {'id': 'H-D-2007-0098'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients', 'description': 'Female breast cancer patients without metastasis and locally advanced disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kenneth Geving Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Henrik Kehlet, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Breast Cancer Cooperative Group', 'class': 'OTHER'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, research fellow', 'investigatorFullName': 'Kenneth Geving Andersen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}