Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:06 AM
Study NCT ID:
NCT03762694
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2018-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-24', 'studyFirstSubmitDate': '2018-12-02', 'studyFirstSubmitQcDate': '2018-12-02', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia Severity Index (ISI)', 'timeFrame': 'week 0, 3, 6 (primary outcome), 10, 14'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'week 0, 3, 6, 10, 14'}, {'measure': 'Sleep diary', 'timeFrame': 'week 0, 6'}, {'measure': 'Actigraphy', 'timeFrame': 'week 0, 6'}, {'measure': 'Functional Assessment of Cancer Therapy-Breast Cancer', 'timeFrame': 'week 0, 6, 10, 14'}, {'measure': 'Adverse events', 'timeFrame': 'week 0 to week 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Insomnia', 'Breast cancer', 'Chemotherapy'], 'conditions': ['Insomnia, Secondary', 'Breast Cancer Female', 'Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '34036813', 'type': 'DERIVED', 'citation': 'Zhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.', 'detailedDescription': 'Hypothesis:\n\nAcupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control.\n\nObjective:\n\nTo determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group.\n\nDesign and strategy:\n\nThis is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list control. All patients in the 2 groups will receive routine Western medical care for symptom management.\n\nStudy instrument:\n\nInsomnia Severity Index (ISI) will be employed as a primary outcome assessment.\n\nIntervention:\n\nIn the treatment group, 12 sessions acupuncture treatment (electroacupuncture \\& auricular acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list control group, no treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as treatment group.\n\nMain outcome measures:\n\nPrimary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.\n\nSecondary outcomes:\n\nPittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer Therapy-Breast Cancer, and adverse events will be documented and compared between groups.\n\nData analysis: The primary endpoint will be the continuous ISI score. For the primary analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test on the average ISI score will be performed to access the significance of the treatment effects; otherwise, a nonparametric approach will be taken.\n\nExpected outcome: ISI score of the acupuncture group is expected to be significantly lower than wait-list control group after 6 weeks of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients between 18 and 75 years of age;\n2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;\n3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;\n4. Insomnia onset after the diagnosis of breast cancer;\n5. Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder;\n6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;\n7. Expected survival time of more than 6 months;\n8. Ability to understand the nature of the study and willingness to give informed consent;\n9. Ability to provide responses during outcome measurement.\n\nExclusion Criteria:\n\n1. Insomnia before the diagnosis of breast cancer;\n2. Other sleep disorder (e.g., obstructive sleep apnoea);\n3. Shift work or irregular sleep pattern;\n4. Severe visual, hearing or language defects;\n5. Severe hematological dysfunction (platelet count \\<60,000/μL, haemoglobin \\<8 g/dL or absolute neutrophil count \\<1000/μL);\n6. With pacemakers or other electronic implants that could interfere with electroacupuncture;\n7. History of acupuncture use in the previous 3 months;\n8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.'}, 'identificationModule': {'nctId': 'NCT03762694', 'briefTitle': 'The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'UW 18-526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture (EA) and Auricular Acupuncture (AA)', 'description': '12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.', 'interventionNames': ['Device: Acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.'}], 'interventions': [{'name': 'Acupuncture', 'type': 'DEVICE', 'description': 'Electroacupuncture (EA) and Auricular Acupuncture (AA)', 'armGroupLabels': ['Electroacupuncture (EA) and Auricular Acupuncture (AA)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor LAO Lixing', 'investigatorAffiliation': 'The University of Hong Kong'}}}}