Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 2:43 PM
Study NCT ID:
NCT01049295
Status:
UNKNOWN
Last Update Posted:
2011-11-01
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-29', 'studyFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2010-01-13', 'lastUpdatePostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP', 'timeFrame': 'first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy'}], 'secondaryOutcomes': [{'measure': 'The serum level of DHA and EPA fatty acids', 'timeFrame': 'first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['taxanes', 'breast cancer', 'n3 fatty acids', 'inflammation'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '22894640', 'type': 'DERIVED', 'citation': 'Ghoreishi Z, Esfahani A, Djazayeri A, Djalali M, Golestan B, Ayromlou H, Hashemzade S, Asghari Jafarabadi M, Montazeri V, Keshavarz SA, Darabi M. Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial. BMC Cancer. 2012 Aug 15;12:355. doi: 10.1186/1471-2407-12-355.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer.', 'detailedDescription': 'Breast cancer is the most common malignancy in women. Chemotherapy with taxanes in patients with breast cancer causes some complications and neuropathy is one of the most frequent that is dose limiting and even may cause to stop the therapy. n-3 fatty acids have very significant role in improvement the function of the neurons.n-3 fatty acids decrease the demyelination and toxicities resulting from taxanes. They also lower the level of of the neurotoxic inflammatory agents. So,n-3 fatty acids improve the quality of life in this patients. 52 patients with invasive breast cancer will be randomized in a double-blind placebo-controlled manner to receive either 640 mg oil fish pearls( 54% DHA, 10% EPA) 3 times a day or placebo( corn oil pearls) for 3 months(during the chemotherapy with taxanes). Neuropathy (using EMG-NCV test)and the level of IL-1,IL-6, TNF-alpha, hs-crp and serum level of EPA and DHA fatty acids will be measured before chemotherapy with taxanes and at the end of the therapy (after 3 months).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish\n\nExclusion Criteria:\n\n* Suffering from the diseases leading to neuropathy, e.g.diabetes, hyperthyroidism, AIDS and primary neural diseases\n* Suffering from any other kind of malignancies\n* Receiving any chemotherapeutical agents in the past'}, 'identificationModule': {'nctId': 'NCT01049295', 'briefTitle': 'Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': '88-04-27-9683'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oil fish pearls', 'description': 'patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day', 'interventionNames': ['Dietary Supplement: oil fish']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day', 'interventionNames': ['Other: corn oil pearls']}], 'interventions': [{'name': 'oil fish', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day', 'armGroupLabels': ['oil fish pearls']}, {'name': 'corn oil pearls', 'type': 'OTHER', 'description': 'corn oil pearls 3 times a day', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Zohreh Ghoreishi, Ph.D student', 'role': 'CONTACT', 'email': 'zghoreishi@razi.tums.ac.ir', 'phone': '0098 912 7390799'}, {'name': 'seyed Ali Keshavarz, professor', 'role': 'CONTACT', 'email': 's_akeshavarz@yahoo.com', 'phone': '0098 912 1279306'}, {'name': 'seyed Ali Keshavarz, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zohreh Ghoreishi, Ph.D student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': ': Tehran University of Medical Sciences, School of Public Health', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Zohreh Ghoreishi, Ph.D student', 'role': 'CONTACT', 'email': 'zghoreishi@razi.tums.ac.ir', 'phone': '0098 912 7390799'}, {'name': 'seyed Ali Keshavarz, professor', 'role': 'CONTACT', 'email': 's_akeshavarz@yahoo.com', 'phone': '0098 912 1279306'}], 'overallOfficials': [{'name': 'Seyed Ali Keshavarz, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}, {'name': 'Zohreh Ghoreishi, Ph.D student', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master of Nutrition', 'investigatorFullName': 'Zohreh Ghoreishi', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}