Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01279018
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2011-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Persistent Pain After Breast Cancer Treatment With Docetaxel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D008209', 'term': 'Lymphedema'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2490}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Docetaxel as a risk factor for development of persistent pain', 'timeFrame': 'Between 2-3 years post surgery'}], 'secondaryOutcomes': [{'measure': 'Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations', 'timeFrame': 'Between 2-3 years post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Persistent postsurgical pain', 'breast cancer', 'postmastectomy pain syndrome', 'neuropathic pain'], 'conditions': ['Breast Neoplasms', 'Pain, Postoperative', 'Neuralgia', 'Lymphedema']}, 'descriptionModule': {'briefSummary': 'Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for breast cancer in Denmark 2007 and 2008', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated for primary breast cancer in Denmark 2007-2008\n* Age between 18-80 years\n* No recurrent cancer\n* Female\n\nExclusion Criteria:\n\n* Previous breast surgery same side (including plastic and reconstructive surgery)\n* Bilateral breast surgery\n* Recurrent cancer or metastatic cancer'}, 'identificationModule': {'nctId': 'NCT01279018', 'briefTitle': 'Persistent Pain After Breast Cancer Treatment With Docetaxel', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Persistent Pain After Breast Cancer Treatment With Docetaxel', 'orgStudyIdInfo': {'id': 'H-1-2010-028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with docetaxel', 'description': 'Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kenneth Geving Andersen, MD', 'oldOrganization': 'Rigshospitalet, Section for Surgical Pathophysiology'}}}}