Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-27 @ 8:22 AM
Study NCT ID:
NCT04589494
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'tramadol or morphine'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in PD1 and PD1ligand', 'timeFrame': 'baseline(0), day15 , day 30', 'description': 'this is flow cytomertic analyses to the human peripheral blood mononuclear cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately.'}], 'secondaryOutcomes': [{'measure': 'pain assessment', 'timeFrame': 'baseline(0), day15 ,day 30', 'description': 'patient describ his pain severty from 0= no pain to 10= the most sever pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['morphine', 'tramadol', 'PD1 and PD1 ligand'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain', 'detailedDescription': 'The use of opioids is the mainstay in the treatment of many types of chronic pain, including cancer and non-cancer-related pain\\]. Opioids are known to suppress immune function following both acute and chronic administration; however, they appear to be different according to the schedule of administration as well as the state of the organism. Programmed death-1 (PD-1, also known as CD279) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with cancer pain of varying etiology,\n* documented metastatic cancer, currently on step I WHO ladder and whose pain necessitates a shift to step II,\n* those who have never received radiotherapy, chemotherapy, or immunosuppressive drugs, -- and in good general and nutritional condition and without infectious diseases at the time of investigation.\n\nExclusion Criteria:\n\n* abnormal hepatic, renal, and pulmonary function, gastrointestinal pathology, and\n* those with cerebral metastases and/or psychological disorders,\n* patients with contraindication to morphine or tramadol according to their respective data sheets, and\n* patients who could not complete the diary information correctly.'}, 'identificationModule': {'nctId': 'NCT04589494', 'briefTitle': 'Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain', 'orgStudyIdInfo': {'id': '493'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tramadol group', 'description': 'tramadol hydrochloride 100 mg three times daily', 'interventionNames': ['Drug: Tramadol Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'morphine group', 'description': 'morphine 30 mg twise times daily', 'interventionNames': ['Drug: Tramadol Hydrochloride']}], 'interventions': [{'name': 'Tramadol Hydrochloride', 'type': 'DRUG', 'otherNames': ['morphine sulphate'], 'description': 'tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily', 'armGroupLabels': ['morphine group', 'tramadol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171516', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sahar A. Mohamed, MD', 'role': 'CONTACT', 'email': 'drsaher2008@yahoo.com', 'phone': '01003611410'}, {'name': 'Shereen M. Mohamed, MD', 'role': 'CONTACT', 'email': 'sheridouh79@yahoo.com', 'phone': '01006279209'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'shereen M Kamal, Associate professor', 'role': 'CONTACT', 'email': 'sheridouh79@yahoo.com', 'phone': '01006279209'}, {'name': 'Hassan M Kotb, Professor', 'role': 'CONTACT', 'email': 'kotbhi@yahoo.com', 'phone': '01287332042'}], 'overallOfficials': [{'name': 'Shereen M Kamal, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lectruer of anesthesia, ICU and pain manegement', 'investigatorFullName': 'Shereen Mamdouh', 'investigatorAffiliation': 'Assiut University'}}}}