Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04872556
Status:
TERMINATED
Last Update Posted:
2024-02-08
First Post:
2021-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The investigators would put eye masking over participants. The care providers would not know the laser acupuncture device or pseudo-laser acupuncture device with randomization. The investigator did not know which group the participants belonged with.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants would be 90 cancer patients accepted Taxanes treatment who are suffered from myalgia and Arthralgia. The investigators would put 45 participants in experimental groups and the other 45 participants in control group with randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'end of the supporting fund', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS on Day 1', 'timeFrame': 'Day 1 after Taxanes treatment', 'description': 'Numerical rating scale in pain evaluation'}, {'measure': 'NRS on Day 3', 'timeFrame': 'Day 3 after Taxanes treatment', 'description': 'Numerical rating scale in pain evaluation'}, {'measure': 'NRS on Day 8', 'timeFrame': 'Day 8 after Taxanes treatment', 'description': 'Numerical rating scale in pain evaluation'}], 'secondaryOutcomes': [{'measure': 'Inflammation assessment', 'timeFrame': 'Day 1 and day 3', 'description': 'Inflammation associated indices: C-Reactive protein'}, {'measure': 'Inflammation assessment', 'timeFrame': 'Day 1 and day 3', 'description': 'Inflammation associated indices: erythrocyte sedimentation rate'}, {'measure': 'Inflammation assessment', 'timeFrame': 'Day 1 and day 3', 'description': 'Inflammation associated indices: Interleukin-6'}, {'measure': 'Functional Assessment of Cancer Therapy-General Scale on Day 1', 'timeFrame': 'Day 1', 'description': 'A Taxanes treatment questionnaire'}, {'measure': 'Functional Assessment of Cancer Therapy-General Scale on Day 3', 'timeFrame': 'Day 3', 'description': 'A Taxanes treatment questionnaire'}, {'measure': 'Functional Assessment of Cancer Therapy-General Scale on Day 8', 'timeFrame': 'Day 8', 'description': 'A Taxanes treatment questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser acupuncture', 'Taxanes', 'Chemotherapy', 'Cancer', 'Myalgia', 'Arthralgia'], 'conditions': ['Pain Cancer', 'Joint Pain']}, 'descriptionModule': {'briefSummary': "This is a prospectively randomized and double-blinded clinical study. Cancer patients were suffered from the taxanes-induced joint pain, and would be advised to receive laser acupuncture in specific points to relieve pain. Clinical effects of analgesic changes would be evaluated before and after the intervention. The inflammation associated indices would be further analyzed to reveal the therapeutic mechanism of laser acupuncture. The laser acupuncture was expected to relief taxanes-induced adverse effects in patients and also can improve patients' life quality.", 'detailedDescription': 'The current clinical study is prospectively randomized and double-blinded, and practice in Chang Gung Memorial Hospital in Linkou, TaoYuan and Taipei branches. All 90 participants suffered from taxanes-induced myalgia and Arthralgia, and will be randomly assigned into the experimental groups (45 participants) and the control group (45 participants). The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment, besides the control group arrange pseudo-laser acupuncture. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cancer patients received taxanes treatment and complained with myalgia and Arthralgia in the first taxanes treatment course.\n2. Age between 20-70 years old\n3. The NRS (numerical rating scale) score of pain increased more than 2 after the treatment.\n4. Both 1st and 2nd taxanes treatment with the same dose\n\nExclusion Criteria:\n\n1. Receiving acupuncture or herbal medicine over past three months\n2. Myalgia and arthralgia were not due to taxanes treatment such osteoarthritis or rheumatic arthritis\n3. Wounds or skin infections over laser acupuncture points\n4. Refuse assign information consent or follow study protocol'}, 'identificationModule': {'nctId': 'NCT04872556', 'briefTitle': 'Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients', 'orgStudyIdInfo': {'id': '202001710A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser acupuncture group', 'description': 'The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment, besides the control group arrange pseudo-laser acupuncture. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.', 'interventionNames': ['Device: Laser acupuncture device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Pseudo-laser acupuncture group', 'description': 'The experiment group would arrange laser acupuncture on day1 and day 3 after Taxanes treatment, besides the control group arrange pseudo-laser acupuncture. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.', 'interventionNames': ['Device: Pseudo-laser acupuncture']}], 'interventions': [{'name': 'Laser acupuncture device', 'type': 'DEVICE', 'description': 'The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.', 'armGroupLabels': ['Laser acupuncture group']}, {'name': 'Pseudo-laser acupuncture', 'type': 'DEVICE', 'description': 'The experiment group would arrange Pseudo-laser acupuncture on day1 and day3 after Taxanes treatment. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.', 'armGroupLabels': ['Pseudo-laser acupuncture group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'ChangGung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}