Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT04947969
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2021-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'After random assignment to 2 groups, patients in the RS and SR groups will receive real and shame laser acupuncture (single blinding), six consecutive times every day.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized controlled, double blind, cross-over study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-06-29', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer-related fatigue evaluation', 'timeFrame': '30 minutes', 'description': 'ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form'}, {'measure': 'Cancer-related fatigue Assessment', 'timeFrame': '15 minutes', 'description': 'Brief Fatigue Inventory-Taiwanese (BFI-T)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Assessments', 'timeFrame': '15 minutes', 'description': 'Functional Assessment of Cancer Therapy-general (FACT-G7)'}, {'measure': 'Symptoms distress Assessments', 'timeFrame': '20 minutes', 'description': 'Taiwanese Version of the M.D. Anderson symptom Inventory (MDASI-T)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser acupuncture'], 'conditions': ['Cancer-related Fatigue']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue', 'detailedDescription': 'This study adopted a randomized controlled design, 2-arm trial cross-over study. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-09). Patients were recruited from the hematology oncology department of Taichung Tzu Chi general hospital. After random assignment to 2 groups, patients in the RS and SR groups will receive real and shame laser acupuncture. Before laser acupuncture, one week later, we will evaluate the patient-reported cancer-related fatigue index and other co-morbid symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18 to 85 years old\n* Patients who signed the informed consent form\n* Patients who have been given a diagnosis of cancer\n* Able to communicate verbally and completely fill the questionnaires\n\nExclusion Criteria:\n\n* Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires'}, 'identificationModule': {'nctId': 'NCT04947969', 'briefTitle': 'Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Tzu Chi Hospital'}, 'officialTitle': 'Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue', 'orgStudyIdInfo': {'id': 'REC110-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rear laser acupuncture group', 'description': 'Patients in the Real laser acupuncture group will receive real laser pen irradiation.', 'interventionNames': ['Device: laser acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Shame laser acupuncture group', 'description': 'Patients in the Shame laser acupuncture group will receive shame laser pen irradiation.', 'interventionNames': ['Device: laser acupuncture']}], 'interventions': [{'name': 'laser acupuncture', 'type': 'DEVICE', 'description': 'This study will use German-made low-level laser pen (Al-Ga-As diode laser, 810nm, NIR, Physiolaser Olympic Basic, RJ laser). The parameters are power of 100mW, frequency of Bahr, apply on acupoint. Well will irradiate each point for 2 J. Each patient will receive this treatment six times for one week.', 'armGroupLabels': ['Rear laser acupuncture group', 'Shame laser acupuncture group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wu Chung Hung, Dr.', 'role': 'CONTACT', 'email': 'wuchunghung1@gmail.com', 'phone': '886-911856726'}, {'name': 'Wu Chung Hung', 'role': 'CONTACT', 'email': 'wuchunghung1@gmail.com', 'phone': '886-911856726'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Tzu Chi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chinese medicine department', 'investigatorFullName': 'Wu Chung Hung', 'investigatorAffiliation': 'Taichung Tzu Chi Hospital'}}}}