Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-01 @ 5:23 PM
Study NCT ID:
NCT03661892
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This a prospective single arm study enrolling patients (n=20) with bone metastases form breast cancer who have been on opioid therapy for bone pain for at least 4 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for opiate pain medication', 'timeFrame': 'Eight weeks', 'description': 'To evaluate change in opiate pain medication use after addition of Syndros.Hypothesis: Syndros will decrease the opiate usage by at least 20% at the end of 8wks. We will evaluate opioid pain medication use by using a drug diary and assessing the percentage change in opiate pain medication requirement at end of 8wks.'}], 'secondaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Eight weeks', 'description': 'To evaluate change in pain using the Brief Pain Inventory tool. Hypothesis: Addition of Syndros will decrease pain intensity on the rating tool.'}, {'measure': 'Change in quality of life', 'timeFrame': 'Eight weeks', 'description': '2\\. To evaluate change in quality of life using the EORTC QLQ-C30 version 3.0 questionnaire. Hypothesis: Addition of Syndros will improve quality of life.'}, {'measure': 'Change in bone modulation', 'timeFrame': 'Eight weeks', 'description': 'To evaluate change in bone modulation by Syndros. Hypothesis: Syndros will decrease bone degradation there by decreasing serum and urine C-terminal telopeptide collagen cross-linker (CTX), N-terminal telopeptide (NTX) and increase osteocalcin.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Bone Metastases', 'Pain', 'Opioid', 'Syndros', 'Bone pain'], 'conditions': ['Bone Metastases', 'Breast Cancer', 'Pain']}, 'descriptionModule': {'briefSummary': 'In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.', 'detailedDescription': 'This a prospective single arm study enrolling patients with bone metastases from breast cancer who have been on opioid therapy for bone pain for at least 4 weeks. All patients start on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study period (total of 8wks). For patients who have side effects secondary to Sydnros, the dose will be decreased. Side effect assessment will be done by the research team 2 days after making the dose adjustment. If subject continues to have side effects, dose will be held until resolution of symptoms. If the study medicine is held for more than a week continuously, they will be taken off the study. In addition, they will have baseline blood and urine collected for biomarkers and also complete study related questionnaires (for secondary end points). They are also provided an opioid drug diary which they will take home during visit 1 to record their opioid pain medication use. Research staff will be calling patients on a weekly basis to reinforce opioid drug diary, assess for Syndros side effect, and adjust dose of Syndros. At the end of 8 weeks blood and urine is collected again and they will complete the study questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study\n2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines\n3. Have metastatic breast cancer with bone metastases\n4. Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff\n5. Age ≥ 21 years\n6. Must be on opioid therapy for bone pain for at least 4 weeks\n\nExclusion Criteria:\n\n1. Have a known sensitivity to dronabinol or alcohol\n2. Have a history of hypersensitivity reaction to alcohol\n3. Using medical marijuana currently\n4. Using Syndros for nausea or appetite stimulant\n5. Receiving or have received disulfiram- or metronidazole- containing products within past 14 days\n6. Are currently pregnant or are of child-bearing age and refuse to use adequate contraception\n7. Have a history of psychiatric illness\n8. Have a history of seizure disorders'}, 'identificationModule': {'nctId': 'NCT03661892', 'briefTitle': 'Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer', 'orgStudyIdInfo': {'id': '1808852902'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01916', 'type': 'REGISTRY', 'domain': 'NCI Trial Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (Syndros)', 'description': 'All patients start on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study period (total of 8wks).', 'interventionNames': ['Drug: Syndros']}], 'interventions': [{'name': 'Syndros', 'type': 'DRUG', 'otherNames': ['Dronabinol'], 'description': 'As noted in arm description. For patients who have side effects secondary to Sydnros, the dose will be decreased as below:\n\nDose subject is taking Reduction recommendation 8.4mg BID Decreased to 8.4mg AM , 4.2mg PM (or it can be 4.2g in AM and 8.4mg in PM- depending on their side effect timing) 8.4mg AM, 4.2mg PM (or vice versa) 4.2mg BID 4.2mg BID 4.2mg once a day 4.2mg once a day Stop and take off study', 'armGroupLabels': ['Treatment (Syndros)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85742', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Pavani Chalasani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}