Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 6:42 AM
Study NCT ID:
NCT00478257
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Increased Light Exposure on Fatigue in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014467', 'term': 'Ultraviolet Therapy'}], 'ancestors': [{'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sancoliisrael@ucsd.edu', 'phone': '858 642-7710', 'title': 'Dr. Sonia Ancoli-Israel', 'organization': 'UCSD'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small sample size; only partial compliance data; light only administered in morning; only tested effect in patients with breast cancer.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Effect of Bright Light', 'description': 'Effect of bright light on fatigue in women with breast cancer', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Effect of Red Light', 'description': 'effect of red light on fatigue in women with breast cancer', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Effect of Bright Light', 'description': 'Effect of bright light on fatigue in women with breast cancer'}, {'id': 'OG001', 'title': 'Effect of Red Light', 'description': 'effect of red light on fatigue in women with breast cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '15.25', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'four cycles of chemotherapy', 'description': 'The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that were randomized and began the protocol were included in analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Effect of Bright Light', 'description': 'Effect of bright light on fatigue in women with breast cancer'}, {'id': 'FG001', 'title': 'Effect of Red Light', 'description': 'effect of red light on fatigue in women with breast cancer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Effect of Bright Light', 'description': 'Effect of bright light on fatigue in women with breast cancer'}, {'id': 'BG001', 'title': 'Effect of Red Light', 'description': 'effect of red light on fatigue in women with breast cancer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '9', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '9', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2007-05-22', 'resultsFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2007-05-22', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-10', 'studyFirstPostDateStruct': {'date': '2007-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'four cycles of chemotherapy', 'description': 'The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fatigue', 'sleep', 'quality of life', 'light', 'cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21660669', 'type': 'RESULT', 'citation': 'Ancoli-Israel S, Rissling M, Neikrug A, Trofimenko V, Natarajan L, Parker BA, Lawton S, Desan P, Liu L. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer. Support Care Cancer. 2012 Jun;20(6):1211-9. doi: 10.1007/s00520-011-1203-z. Epub 2011 Jun 11.'}, {'pmid': '22865153', 'type': 'RESULT', 'citation': 'Jeste N, Liu L, Rissling M, Trofimenko V, Natarajan L, Parker BA, Ancoli-Israel S. Prevention of quality-of-life deterioration with light therapy is associated with changes in fatigue in women with breast cancer undergoing chemotherapy. Qual Life Res. 2013 Aug;22(6):1239-44. doi: 10.1007/s11136-012-0243-2. Epub 2012 Aug 3.'}, {'pmid': '22742438', 'type': 'RESULT', 'citation': 'Neikrug AB, Rissling M, Trofimenko V, Liu L, Natarajan L, Lawton S, Parker BA, Ancoli-Israel S. Bright light therapy protects women from circadian rhythm desynchronization during chemotherapy for breast cancer. Behav Sleep Med. 2012;10(3):202-16. doi: 10.1080/15402002.2011.634940.'}, {'pmid': '35356054', 'type': 'DERIVED', 'citation': 'Rissling M, Liu L, Youngstedt SD, Trofimenko V, Natarajan L, Neikrug AB, Jeste N, Parker BA, Ancoli-Israel S. Preventing Sleep Disruption With Bright Light Therapy During Chemotherapy for Breast Cancer: A Phase II Randomized Controlled Trial. Front Neurosci. 2022 Mar 9;16:815872. doi: 10.3389/fnins.2022.815872. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Patients treated with chemotherapy complain of poor sleep, fatigue and depression. In addition, chemotherapy disrupts the body\'s internal "biological clock", which may make sleep, fatigue and depression all worse. Women with breast cancer undergoing chemotherapy are not exposed to much bright light and this may also contribute to the disruption of their body clock, because bright light is necessary for a strong biological clock. One of the easiest ways to strengthen the biological clock is by increasing bright light exposure. The correct timing of the light exposure will help the women feel more alert during the day.', 'detailedDescription': 'Patients treated with chemotherapy complain of poor sleep, fatigue and depression. Our preliminary research suggests that these symptoms may all be related, that chemotherapy disrupts circadian rhythms which may exacerbate the poor sleep and fatigue and that during chemotherapy, women are not exposed to much bright light which likely also contributes to the disruption of rhythms. One of the easiest circadian rhythms to measure is sleep/wake activity and the easiest way to synchronize this rhythm is with bright light treatment. It is well established that bright light exposure will make rhythms more robust, and the correct timing of the light exposure will have an alerting effect.\n\nWe hypothesize that after bright light treatment compared to dim light treatment during three cycles of chemotherapy: fatigue (measured by the Multidimensional Fatigue Symptom Inventory), depression (measured by the Center of Epidemiological Studies-Depression scale), functional outcome scores (measured by the Functional Outcome of Sleep Questionnaire and by the Functional Assessment of Cancer Therapy-Breast), and sleep measures (measured by actigraphy, e.g., total sleep time, total wake time, bouts of sleep, napping) will all be improved. We also hypothesize that circadian rhythms (measured by actigraphy) will be more robust and more synchronized.\n\nThe aims are to examine the effect of bright light treatment on subjective measures of fatigue, mood and functional outcome experienced during chemotherapy, to examine the effect of bright light treatment on the quality and quantity of sleep during chemotherapy, to examine the effect of bright light treatment on sleep/wake rhythms during chemotherapy. Women with breast cancer stages I-III scheduled to begin chemotherapy will be recruited. Wrist actigraphy data (for the measurement of sleep/wake activity) will be collected for three consecutive days and nights immediately preceding chemotherapy and questionnaire data (fatigue, mood, quality of life, functional outcome, sleep) will be collected during this same time period. Half the women will be randomized to receive bright light and the other half to dim red light as a control. Daily bright light or dim light treatment will be administered during cycles 2, 3 and 4 of chemotherapy and all measures (actigraphy and questionnaires) will be repeated during the first and last weeks of cycle 1 and cycle 4 chemotherapy. If bright light can improve sleep rhythms and fatigue, then the quality of life of these women is likely to improve.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage I-III breast cancer\n* adjuvant or neoadjuvant anthracycline-based chemotherapy\n\nExclusion Criteria:\n\n* under age 18\n* pregnancy\n* metastatic or inoperable (including inflammatory) breast cancer\n* confounding underlying medical illnesses\n* history of mania\n* history of other axis-I psychiatric disorder\n* other physical or psychological impairments -'}, 'identificationModule': {'nctId': 'NCT00478257', 'briefTitle': 'Effect of Increased Light Exposure on Fatigue in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Effect of Increased Light Exposure on Fatigue in Breast Cancer', 'orgStudyIdInfo': {'id': 'CBCRP 11IB-0034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Active Bright White Light Treatment', 'description': 'Intervention: Bright white light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy', 'interventionNames': ['Device: bright white light']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Comparator Red Light Treatment', 'description': 'Intervention: Dim red light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy', 'interventionNames': ['Device: comparator red light treatment']}], 'interventions': [{'name': 'bright white light', 'type': 'DEVICE', 'description': 'Intervention: Bright white light administered for 30 minutes each morning', 'armGroupLabels': ['1 Active Bright White Light Treatment']}, {'name': 'comparator red light treatment', 'type': 'DEVICE', 'description': 'dim red light administered for 30 minutes every morning', 'armGroupLabels': ['2 Comparator Red Light Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Sonia Ancoli-Israel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Breast Cancer Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sonia Ancoli-Israel', 'investigatorAffiliation': 'University of California, San Diego'}}}}