Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-04-05 @ 3:34 AM
Study NCT ID:
NCT03631004
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2018-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-21', 'releaseDate': '2023-09-06'}, {'resetDate': '2025-04-24', 'releaseDate': '2025-04-07'}], 'estimatedResultsFirstSubmitDate': '2023-09-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2018-08-11', 'studyFirstSubmitQcDate': '2018-08-11', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': '0-24 hours', 'description': 'nausea and vomiting/ retching (dichotomous variable)'}], 'secondaryOutcomes': [{'measure': 'incidence of side effects', 'timeFrame': '0-6 hours', 'description': 'side effects'}, {'measure': 'incidence of side effects', 'timeFrame': '0-24 hours', 'description': 'side effects'}, {'measure': 'incidence of side effects', 'timeFrame': '24-48 hours', 'description': 'side effects'}, {'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': '0-6 hours', 'description': 'nausea and vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': '24-48 hours', 'description': 'nausea and vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative nausea', 'timeFrame': '0-6 hours', 'description': 'nausea and vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative nausea', 'timeFrame': '0-24 hours', 'description': 'nausea and vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative nausea', 'timeFrame': '24-48 hours', 'description': 'nausea and vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative vomiting/retching', 'timeFrame': '0-6 hours', 'description': 'vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative vomiting/retching', 'timeFrame': '0-24 hours', 'description': 'vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of postoperative vomiting/retching', 'timeFrame': '24-48 hours', 'description': 'vomiting/ retching (dichotomous variable)'}, {'measure': 'incidence of severe PONV', 'timeFrame': '0-6 hours', 'description': 'This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important.'}, {'measure': 'incidence of severe PONV', 'timeFrame': '0-24 hours', 'description': 'This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important.'}, {'measure': 'incidence of severe PONV', 'timeFrame': '24-48 hours', 'description': 'This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important.'}, {'measure': 'incidence of nausea severity', 'timeFrame': '0-6 hours', 'description': 'mild, moderate, or severe'}, {'measure': 'incidence of nausea severity', 'timeFrame': '0-24 hours', 'description': 'mild, moderate, or severe'}, {'measure': 'incidence of nausea severity', 'timeFrame': '24-48 hours', 'description': 'mild, moderate, or severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nausea and vomiting'], 'conditions': ['Postoperative Nausea', 'Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.\n\nThe project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.', 'detailedDescription': "Double blinded randomized clinical trial. Fifty patients will be selected for each group. Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in the preoperative period. Both groups will receive intravenous general anesthesia combined with epidural. All patients will receive epidural PCA.\n\nThe primary outcome of this study is the incidence of post-operative nausea and vomiting. The power of analysis was based on the following parameters: type error I (α = 0.05), error II (β = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. The population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group.\n\nThe statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data.\n\nFor quantitative variables, the Student's t-test will be used for with normal distribution or Mann-Whitney for non-distributed data normal.\n\nFor qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p, 0.05.\n\nData will be collected and managed using REDCap data capture tools"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia\n* Patients aged between 18 and 60 years\n* Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)\n* Patients with a history of chemotherapy-induced nausea and vomiting.\n\nExclusion criteria:\n\n* Pregnancy or Lactation\n* Current use of typical anti-psychotic medications or atypical\n* History of allergy to olanzapine\n* Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning\n* History of severe ventricular arrhythmia (eg, VT or VF)\n* Heart Failure Class II or greater second NYHA\n* Postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning\n* Narrow angle glaucoma\n* Parkinson's disease\n* Dementia\n* Inability to swallow medicines\n* QT interval history greater than 450ms or torsades de pointes\n* Patient does not want to participate in the study\n* Videolaparoscopy surgery\n* Contraindication for neuraxial block"}, 'identificationModule': {'nctId': 'NCT03631004', 'briefTitle': 'Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients', 'orgStudyIdInfo': {'id': '1287/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'olanzapine tablets', 'description': 'PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY', 'interventionNames': ['Drug: Olanzapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Starch tablets', 'description': 'PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY', 'interventionNames': ['Drug: Olanzapine']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['Treatment'], 'description': 'olanzapine 10 mg is given before surgery', 'armGroupLabels': ['Starch tablets', 'olanzapine tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Cancer Institute of the State of Sao Paulo - ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Roger Chammas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto do Cancer do Estado de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-06', 'type': 'RELEASE'}, {'date': '2024-03-21', 'type': 'RESET'}, {'date': '2025-04-07', 'type': 'RELEASE'}, {'date': '2025-04-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Instituto do Cancer do Estado de São Paulo'}}}}