Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-23 @ 5:19 AM
Study NCT ID:
NCT02069067
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2014-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010148', 'term': 'Pain, Intractable'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2014-02-20', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients who experience BTcP', 'timeFrame': 'one year'}, {'measure': 'treatments used to treat BTcP', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': '4 weeks', 'description': 'evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication'}, {'measure': 'time to pain relief of BTcP', 'timeFrame': '4 weeks'}, {'measure': 'initial dose of therapy (in morphine equivalents) for BTcP', 'timeFrame': '4 weeks', 'description': 'to verify a correlation between initial dose for BTcP and daily dose of baseline pain therapy'}, {'measure': 'effective dose for BTcP', 'timeFrame': '4 weeks', 'description': 'to verify a correlation between effective dose for BTcP and daily dose of baseline pain therapy (dose reported in morphine equivalents)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breakthrough cancer pain', 'pain', 'neuropathic pain', 'intractable pain', 'cancer'], 'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced cancer and chronic pain being controlled with opiods.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of neoplasm in advanced stage\n* Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent\n* 1-6 episodes of BTcP within any of 3 days previous to registration into study\n* Signed Informed Consent\n\nExclusion Criteria:\n\n· More than 6 episodes of BTcP within any of 3 days previous to registration into study'}, 'identificationModule': {'nctId': 'NCT02069067', 'acronym': 'Break-1', 'briefTitle': 'Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain', 'orgStudyIdInfo': {'id': 'Break-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced cancer patients with pain'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Castellammare di Stabia', 'country': 'Italy', 'facility': 'Ospedale San Leonardo', 'geoPoint': {'lat': 40.70211, 'lon': 14.48685}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale dei Tumori , Unita Terapia Antalgica', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Nola', 'country': 'Italy', 'facility': 'S. Maria della Pietà', 'geoPoint': {'lat': 40.92606, 'lon': 14.52816}}], 'overallOfficials': [{'name': 'Arturo Cuomo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI Naples, Division of Pain Therapy'}, {'name': 'Francesco Perrone, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI Naples, Clinical Trials Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}