Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-19 @ 3:28 AM
Study NCT ID:
NCT03640195
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012639', 'term': 'Seeds'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention is divided into two parts: part of The Experimental group received Transcutaneous acupoint electrical stimulation 20 minutes/weeks, the acupoints are unilateral Hegu (LI4) and LU7; This study used Transcutaneous nerve electrical stimulation , 20 minutes each time, once a week for six consecutive weeks.\n\nThe second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3).A seeds embedding method with seeds attached to the four sides of the unilateral ear, using the thumb and forefinger to apply pressure, the participants will feel sour, each point is 1min, 5days/week, 3 times/day.\n\nControl group: without intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks', 'timeFrame': 'from enrollment to end of treatment at 6 weeks', 'description': 'Pain intensity was assessed using visual analogue scales (VAS) , which is a 10-cm continuous line to assess the subjective perception of pain in the case, with a score of 0 on the leftmost end of the line indicating "painless" and 10 points indicating The "most severe pain" and the reliability of pain assessment , and all participants received this linear tool measurement, recording a total of five'}], 'secondaryOutcomes': [{'measure': 'Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks', 'timeFrame': 'from enrollment to end of treatment at 6 weeks', 'description': 'Fatigue is using the friction fatigue inventory (BFI) ; it is a nitrate-item self-reported for measuring fatigue intensity and interference with functionality. Item 1-3 describes the fatigue strength, during The past 24 hour using a visual analogue scale (VAS) ranging from 0 (no fatigue) to 10 (very severely fatigued). Item 4-9 describes interferes with certain functions such as daily activity, including work, walking ability, normal work, Relations with others, and enjoyment in life. Each item was rated on a scale of 0 (does not interfere) to 10 (completely interferes). Its average score for each item indicates its severity of fatigue 1-3 points of helpful mild fatigue, 4 -6 is divided into moderate, 7-10 is divided into severe fatigue.'}, {'measure': 'Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale', 'timeFrame': 'from enrollment to end of treatment at 6 weeks', 'description': 'The Hospital Anxiety and depression scale (HADS) is composed of two seven-item subscales, one specifically targeting anxiety (HADS-A) and the other focusing on depression (HADS-D). The HADS is a 14-item measure divided into 2 subscales (anxiety and depression), HADS\\_A and HADS\\_D are scored separately, the topic arrangement is staggered, and the reverse problem is scored in reverse. The total score is between 0-21 points. Below 8 points means no anxiety and depression; 8 to 10 points may be anxiety and depression. And anxiety and depression of 10 points or more'}, {'measure': 'Difference between the two groups from Baseline in quality of life European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H & N 35)', 'timeFrame': 'from enrollment to end of treatment at 6 weeks', 'description': 'European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H \\& N 35) is a specific questionnaire developed by the European Organisation for Research and Treatment of Cancer for head and neck cancer. The module includes 35 questions Assessing symptoms and side effects of treatment, social function and body image/sexuality .This scale includes seven symptoms subscales that measure pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social Contact, and less sexuality, and also has 11 subscales related with teeth, opening mouth, dry mouth, sticky saliva, coughing, ill feeling, weight loss, weight gain, use of painkillers, nutritional supplements, and feeding tubes. Standardize the original scores, with scores ranging from 0 to 100, with higher scores representing more serious problems.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '35528798', 'type': 'DERIVED', 'citation': 'Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy.', 'detailedDescription': 'Data were collected from 92 participants in northern Taiwan medical center Radiation Outpatient.They are randomly assigned to the experimental group (n=46) with Acupoint stimulation and control group(n=46). Outcomes were assessed according to the pain, Brief fatigue inventory, Hospital anxiety and depression scale, quality of life, five repeated measures was conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy\n* Must be able to communicate clearly\n* Must be above age 20\n\nExclusion Criteria:\n\n* Previous radiotherapy\n* History of arrhythmia or use of a pacemaker\n* Local swelling or infection over the acupoint area'}, 'identificationModule': {'nctId': 'NCT03640195', 'briefTitle': 'Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Acupoint Stimulation for Pain Reduction', 'orgStudyIdInfo': {'id': 'yahe7693'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Transcutaneous nerve electrical stimulation and Auricular acupressure.', 'interventionNames': ['Other: Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'without intervention'}], 'interventions': [{'name': 'Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure', 'type': 'OTHER', 'description': 'Experimental group received Acupoint stimulation, Transcutaneous acupoint electrical stimulation20 minutes/weeks, once a week for six consecutive weeks.\n\nThe second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3). each point is 1min, 5days/week, 3 times/day.', 'armGroupLabels': ['Experimental group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}