Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 2:27 AM
Study NCT ID:
NCT01695993
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alternative Approaches for Nausea Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joseph_roscoe@urmc.rochester.edu', 'phone': '585 275-9962', 'title': 'Joseph A. Roscoe, PhD Associate Research Professor', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'two months', 'description': 'We used a standard definition for adverse events, but because this was a minimal risk study, our IRB required us to report and record only SAEs that were possibly, probably, or definitely related to the study intervention. See Section 5.7.1.1 of the protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Patients will receive only standard care', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Patients receive:\n\n1. Handout without expectancy- enhancing component\n2. Relaxation MP3 without expectancy-enhancing component\n3. Acupressure bands', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3', 'description': 'Patients receive:\n\n1. Handout with expectancy- enhancing component\n2. Relaxation MP3 with expectancy-enhancing component\n3. Acupressure bands', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Report Nausea Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Patients receive only standard care'}, {'id': 'OG001', 'title': 'Expectancy-Neutral Condition', 'description': '* Handout without expectancy- enhancing component\n* Relaxation MP3 without expectancy-enhancing component\n* Acupressure bands'}, {'id': 'OG002', 'title': 'Expectancy-Enhancing Condition', 'description': '* Handout with expectancy-enhancing component\n* Relaxation MP3 with expectancy-enhancing component\n* Acupressure bands'}], 'classes': [{'categories': [{'measurements': [{'value': '3.87', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '3.52', 'spread': '1.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03', 'pValueComment': 'Not adjusted', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'five days', 'description': 'Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The outcome variable for the primary analysis was greatest reported nausea from the five day period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1', 'description': 'Patients receive standard care only'}, {'id': 'FG001', 'title': 'Arm 2', 'description': 'Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component\n\n\\- Acupressure bands'}, {'id': 'FG002', 'title': 'Arm 3', 'description': 'Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'To ill to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Changed Medical Facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1', 'description': 'Patients will receive only standard care'}, {'id': 'BG001', 'title': 'Arm 2', 'description': '* Handout without expectancy- enhancing component\n* Relaxation MP3 without expectancy-enhancing component\n* Acupressure bands'}, {'id': 'BG002', 'title': 'Arm 3', 'description': '* Handout with expectancy- enhancing component\n* Relaxation MP3 with expectancy-enhancing component\n* Acupressure bands'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '53', 'spread': '11.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-26', 'size': 680197, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-03-23T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2012-09-26', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-27', 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Report Nausea Diary', 'timeFrame': 'five days', 'description': 'Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The outcome variable for the primary analysis was greatest reported nausea from the five day period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nausea', 'Quality of life', 'Chemotherapy', 'Expectancy'], 'conditions': ['Nausea']}, 'descriptionModule': {'briefSummary': '216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.\n\nHypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea', 'detailedDescription': "Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be female.\n* Have a diagnosis of breast cancer, any stage.\n* Be chemotherapy naïve and about to begin her first course of chemotherapy.\n* Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:\n\n 1. Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \\& 3.\n 2. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \\& 3.\n 3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \\& 3.\n 4. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \\& 3.\n\nNote: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.\n\n* Have a response of \\> 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = "I am certain I WILL NOT have this," and at the other end by 5 = "I am certain I WILL have this."\n* Be able to read English (since the assessment materials are in printed format).\n* Be 18 years of age or older and give written informed consent.\n\nExclusion Criteria:\n\n* Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.\n* Be receiving concurrent radiotherapy or interferon.'}, 'identificationModule': {'nctId': 'NCT01695993', 'briefTitle': 'Alternative Approaches for Nausea Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Alternative Approaches for Nausea Control', 'orgStudyIdInfo': {'id': 'UCCS1202'}, 'secondaryIdInfos': [{'id': 'R01AT007474-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AT007474-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1 - Standard Care Only', 'description': 'Patients will receive standard care only'}, {'type': 'OTHER', 'label': 'Arm 2 - Expectancy-neutral Arm', 'description': 'Patients receive:\n\n1. Expectancy-neutral handout\n2. Expectancy-neutral MP3\n3. Acupressure bands', 'interventionNames': ['Device: Acupressure bands', 'Other: Expectancy-neutral handout', 'Behavioral: Expectancy-neutral MP3']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 - Expectancy-enhancing Arm', 'description': 'Patients receive:\n\n1. Expectancy-enhancing handout\n2. Expectancy-enhancing MP3\n3. Acupressure bands', 'interventionNames': ['Device: Acupressure bands', 'Other: Expectancy-enhancing handout', 'Behavioral: Expectancy-enhancing MP3']}], 'interventions': [{'name': 'Acupressure bands', 'type': 'DEVICE', 'description': 'Bilateral acupressure wrist bands', 'armGroupLabels': ['Arm 2 - Expectancy-neutral Arm', 'Arm 3 - Expectancy-enhancing Arm']}, {'name': 'Expectancy-neutral handout', 'type': 'OTHER', 'description': 'The expectancy neutral handout has neutral information regarding the acupressure bands', 'armGroupLabels': ['Arm 2 - Expectancy-neutral Arm']}, {'name': 'Expectancy-neutral MP3', 'type': 'BEHAVIORAL', 'description': 'Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.', 'armGroupLabels': ['Arm 2 - Expectancy-neutral Arm']}, {'name': 'Expectancy-enhancing handout', 'type': 'OTHER', 'description': 'The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands', 'armGroupLabels': ['Arm 3 - Expectancy-enhancing Arm']}, {'name': 'Expectancy-enhancing MP3', 'type': 'BEHAVIORAL', 'description': 'Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.', 'armGroupLabels': ['Arm 3 - Expectancy-enhancing Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Hematology-Oncology Associates of Central New York', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '14621', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': "Rochester General Hospital's Lipson Cancer and Blood Center", 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester James P. Wilmot Cancer Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Joseph A Roscoe, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Joseph Roscoe', 'investigatorAffiliation': 'University of Rochester'}}}}