Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00832520
Status:
TERMINATED
Last Update Posted:
2018-04-10
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078785', 'term': 'Mirtazapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vparks@salud.unm.edu', 'phone': '505-925-0390', 'title': 'Valerie Parks, RN', 'organization': 'UNM Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to no subjects analyzed.There will be no publication, as this study was terminated after the original PI left employment with the institution.'}}, 'adverseEventsModule': {'description': 'Regular investigator assessment, regular laboratory testing, and self-reporting by subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Remeron (Mirtazapine)', 'description': 'Mirtazapine 15 mg orally at bed time for 8 weeks', 'otherNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remeron (Mirtazapine)', 'description': 'Mirtazapine 15 mg orally at bed time for 8 weeks'}], 'timeFrame': '8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.'}, {'type': 'SECONDARY', 'title': 'To Determine if the Quality of Life Improves After Starting Mirtazapine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remeron (Mirtazapine)', 'description': 'Mirtazapine 15 mg orally at bed time for 8 weeks'}], 'timeFrame': '8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remeron (Mirtazapine)', 'description': 'Mirtazapine 15 mg orally at bed time for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible. The recruitment period spanned 07Apr2009 through 14Jul2010. All were recruited through the UNM Cancer Center medical clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Remeron (Mirtazapine)', 'description': 'Mirtazapine 15 mg orally at bed time for 8 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Low accrual rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2009-01-29', 'resultsFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-19', 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'To Determine if the Quality of Life Improves After Starting Mirtazapine', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced cancer', 'weight loss', 'Remeron', 'body weight'], 'conditions': ['Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '36999619', 'type': 'DERIVED', 'citation': 'Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if remeron, also called mirtazapine, can help you prevent weight loss while on treatment for your cancer. Remeron is currently used to treat depression and has not been approved by the Food and Drug Administration for use to treat weight loss.', 'detailedDescription': 'Weight loss in cancer patients can be the result of inadequate intake or absorption of nutrients and/or tumor-induced weight loss due to metabolic changes the tumor is creating in the body (1). Inadequate intake resulting in a starvation state can simply be the result of eating less due to depression, nausea/vomiting, feelings of fullness, and taste changes (2). Though not intentional the weight loss caused by these symptoms can be explained and reversed by increasing intake of nutrients. Unintentional weight loss induced by the tumor can be caused by multiple physiological factors that increase the catabolism of muscle and fat and increased nutrient intake alone may not reverse the weight loss. Unintentional weight loss can predict a poor prognosis in cancer patients which is most likely due to decreased doses of treatment (3-5).\n\nUsual care for weight loss in cancer patients varies among practitioners and can include nutrition counseling by a registered dietitian or by the practitioner themselves. Treatment can vary from counseling patients to increase intake of nutrient dense foods to prescribing medications in order to improve appetite or mood, to decrease feelings of fullness, or to control nausea/vomiting, etc. (6). However, these interventions do not always work. For varied reasons not all patients are able to improve their oral intake of food items and in patients with tumor induced weight loss increased oral intake does not improve the metabolic changes.\n\nAnti-depressant medications have weight related side effects (7-9). Mirtazapine has been shown to have side effects of increased appetite and increased weight in cancer subjects studied for use with depression and nausea. (10-13). These results appeared to range from changes in appetite to changes seen in metabolic processes such as changes in the cytokine system to reduce inflammation seen in cachectic patients. Therefore, using mirtazapine in cancer patients even without depression may help to stop unwanted weight loss and increase survival by allowing patient to complete prescribed treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients, 18 years of age or older, with advanced cancer are eligible.\n2. Patients must have lost 10% in the last 6 months\n3. Patients must have a life expectancy of at least 12 weeks.\n4. Patients must have a Zubrod performance status of 0-3.\n5. Patients must sign an informed consent.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases are excluded from this study.\n2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.\n3. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.\n4. Patients with head and neck cancers and GI cancers who have functional problems that limits food intake or absorption of nutrients such as partial or complete bowel obstructions, and patients with skin cancers (except melanoma) are not eligible\n5. Patients who lost weight on a voluntary diet.\n6. Patients who are already taking an appetite stimulant or other anti-depressant, except for SSRI taken in the morning.\n7. Patients who had surgery in the last 6 months'}, 'identificationModule': {'nctId': 'NCT00832520', 'briefTitle': 'Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico Cancer Research Alliance'}, 'officialTitle': 'INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight', 'orgStudyIdInfo': {'id': 'INST 0816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remeron (Mirtazapine)', 'description': 'Mirtazapine 15 mg orally at bed time for 8 weeks', 'interventionNames': ['Drug: Remeron (mirtazapine)']}], 'interventions': [{'name': 'Remeron (mirtazapine)', 'type': 'DRUG', 'otherNames': ['mirtazapine'], 'description': 'Mirtazapine 15 mg orally at bed time. Patients with a creatinine clearance \\< 50% or a bilirubin or transaminases \\> twice the upper limit of normal will take a 7.5 mg dose.\n\n* Drug Administration: Drug will be administered orally, every day for a period of 8 weeks\n* Dose modifications: None', 'armGroupLabels': ['Remeron (Mirtazapine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center @ Lovelace Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Universtiy of New Mexico - Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Claire Verschraegen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}