Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-30 @ 8:12 AM
Study NCT ID:
NCT03095157
Status:
UNKNOWN
Last Update Posted:
2017-03-29
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery', 'timeFrame': '3 months', 'description': 'Persistent pain after thoracic surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled', 'Persistent Post Surgical Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. In addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled to undergo esophagectomy at BWH\n* 18-80 years old\n\nExclusion Criteria:\n\n* pre-existing chronic pain\n* current opioid use\n* current treatment with corticosteroids\n* evidence of active infection\n* chronic liver disease\n* end-stage renal disease (CKD-5)\n* chronic inflammatory disorders\n* recent major surgery or illness within 30 days\n* use of immunosuppressive medication\n* history of organ transplant\n* pregnancy or plans to become pregnant\n* lactating\n* allergies to fish or fish oil'}, 'identificationModule': {'nctId': 'NCT03095157', 'briefTitle': 'The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery', 'orgStudyIdInfo': {'id': '2017P000346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil']}], 'interventions': [{'name': 'fractionated marine lipid concentrate derived from anchovy and sardine oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will be randomized to receive perioperative treatment versus placebo', 'armGroupLabels': ['Placebo', 'Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mieke Soens, MD', 'role': 'CONTACT', 'email': 'msoens@partners.org', 'phone': '617-732-6798'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Staff Anesthesiologist', 'investigatorFullName': 'Mieke A. Soens', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}