Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-20 @ 6:29 AM
Study NCT ID:
NCT05397457
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Helmet Type, Home-use Low-level Light Therapy Device for Chemotherapy-induced Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hair counts recorded by Sentra scalp analyzer', 'timeFrame': 'Baseline', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair counts recorded by Sentra scalp analyzer', 'timeFrame': '12th course of intervention (four weeks after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.'}], 'secondaryOutcomes': [{'measure': 'Chemotherapy-Induced Alopecia Distress Scale', 'timeFrame': 'Baseline', 'description': 'A validated questionnaire was developed by the Korean Organization for Researching distress due to chemotherapy-induced alopecia.\n\nThe minimum and maximum scores on the chemotherapy-induced alopecia distress scale are 17 and 68, respectively, including 17 items in 4 factors (Physical, emotional, activity, and relationship). The higher value suggests higher chemotherapy-induced distress that the participants encountered.'}, {'measure': 'Chemotherapy-Induced Alopecia Distress Scale', 'timeFrame': '12th course of intervention (four weeks after the first course of intervention)', 'description': 'A validated questionnaire was developed by the Korean Organization for Researching distress due to chemotherapy-induced alopecia.\n\nThe minimum and maximum scores on the chemotherapy-induced alopecia distress scale are 17 and 68, respectively, including 17 items in 4 factors (Physical, emotional, activity, and relationship). The higher value suggests higher chemotherapy-induced distress that the participants encountered.'}, {'measure': 'Rosenberg Self-esteem Scale', 'timeFrame': 'Baseline', 'description': "Self-esteem will be measured by Rosenberg's Self-Esteem scale with 10 items. Each item is scored on a 4-point Likert self-report scale, ranging from 0 to 3. A total score is obtained by summing all item scores. The minimum and maximum scores on the scale are 0 and 30. Scoring less than 15 may indicate problematic low self-esteem."}, {'measure': 'Rosenberg Self-esteem Scale', 'timeFrame': '12th course of intervention (four weeks after the first course of intervention)', 'description': "Self-esteem will be measured by Rosenberg's Self-Esteem scale with 10 items. Each item is scored on a 4-point Likert self-report scale, ranging from 0 to 3. A total score is obtained by summing all item scores. The minimum and maximum scores on the scale are 0 and 30. Scoring less than 15 may indicate problematic low self-esteem."}, {'measure': 'European Quality of Life 5 Dimensions 5 Level Version', 'timeFrame': 'Baseline', 'description': "The European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems, indicating his/her health state by ticking the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined into a 5-digit number describing the respondent's health state and divided into 5 levels of perceived problems:\n\nLevel 1: no problem Level 2: slight problems Level 3: moderate problems Level 4: severe problems Level 5: extreme problems"}, {'measure': 'European Quality of Life 5 Dimensions 5 Level Version', 'timeFrame': '12th course of intervention (four weeks after the first course of intervention)', 'description': "The European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems, indicating his/her health state by ticking the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined into a 5-digit number describing the respondent's health state and divided into 5 levels of perceived problems:\n\nLevel 1: no problem Level 2: slight problems Level 3: moderate problems Level 4: severe problems Level 5: extreme problems"}, {'measure': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire', 'timeFrame': 'Baseline', 'description': 'The European Organization for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.\n\nThe 30-item questionnaire measuring QLQ (QLQ-C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.\n\nEach of the multi-item scales includes a different set of items - no item occurs in more than one scale.\n\nAll of the scales and single-item measures range in score from 0 to 100. The high scale score represents a high response level.\n\nThus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems'}, {'measure': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire', 'timeFrame': '12th course of intervention (four weeks after the first course of intervention)', 'description': 'The European Organization for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.\n\nThe 30-item questionnaire measuring QLQ (QLQ-C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.\n\nEach of the multi-item scales includes a different set of items - no item occurs in more than one scale.\n\nAll of the scales and single-item measures range in score from 0 to 100. The high scale score represents a high response level.\n\nThus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems'}, {'measure': 'Hair width recorded by Sentra scalp analyzer', 'timeFrame': 'Baseline', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair width in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair counts recorded by Sentra scalp analyzer', 'timeFrame': '3rd course of intervention (one week after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair width recorded by Sentra scalp analyzer', 'timeFrame': '3rd course of intervention (one week after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair width in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair counts recorded by Sentra scalp analyzer', 'timeFrame': '6th course of intervention (two weeks after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair width recorded by Sentra scalp analyzer', 'timeFrame': '6th course of intervention (two weeks after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair width in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair counts recorded by Sentra scalp analyzer', 'timeFrame': '9th course of intervention (three weeks after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair width recorded by Sentra scalp analyzer', 'timeFrame': '9th course of intervention (three weeks after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair width in the frontal, parietal, and occipital regions.'}, {'measure': 'Hair width recorded by sentra scalp analyzer', 'timeFrame': '12th course of intervention (four weeks after the first course of intervention)', 'description': 'Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair width in the frontal, parietal, and occipital regions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Chemotherapy-induced Alopecia']}, 'referencesModule': {'references': [{'pmid': '38053197', 'type': 'DERIVED', 'citation': 'Wu CX, Li CH, Shiao YH, Cheng HY, Wu TH, Lee CH, Chang ZY, Yeh YC. The effect of a helmet type, home-use low-level light therapy device for chemotherapy-induced alopecia: study protocol for a randomized controlled trial. Trials. 2023 Dec 5;24(1):789. doi: 10.1186/s13063-023-07823-x.'}]}, 'descriptionModule': {'briefSummary': "As far as breast cancer is concerned, chemotherapy (CT) is an important treatment. However, there are many adverse effects impairing the patient's quality of life (QOL), in which chemotherapy-induced alopecia (CIA) affects up to 65% of the patients. This condition is reversible. Nevertheless, it takes several months after CT for visible hair regrowth. Different characteristics of the new hair are common; for example, 65 percent of the patients have experienced a graying, curling, or straightening effect. Besides, the emotional trauma due to alopecia can not be neglected.\n\nCurrently, scalp cooling is the only available and verified management for prevention. Unfortunately, the success rate of scalp cooling is variable, especially among the patients receiving anthracycline-based combinations.\n\nLow-level light therapy (LLLT) has been proven as a therapeutic technique for adrenergic alopecia. Recently, investigators have checked the validity of LLLT for the CIA. Although the preliminary outcome showed failure at accelerating hair recovery, technical progress of LLLT may improve the end result. Specifically, LLLT is a technique that utilizes laser diodes (LD) or light-emitting diodes (LED) to promote tissue repair. The light source from LD is coherent while LED is an incoherent light source. Therefore, LDs can deliver energy to tissues more efficiently than LEDs. To comprehensively evaluate the beneficial effect of LLLT in treating CIA, we conduct a clinical trial with a more advanced device equipped with 69 LDs.\n\nThe project aims to explore the effect of low-level light therapy in chemotherapy-induced alopecia. We expect the therapy will lead to an improvement in the patient's hair count, hair width, and quality of life after chemotherapy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20 to 75 years\n* Informed Consent as documented by signature.\n* Able to read and converse in chinese\n* Female\n* Diagnosis of breast cancer\n* They completed chemotherapy no more than 2 weeks\n* Treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen.\n* life expectancy was at least 6 months.\n* Diagnosed with CIA grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE)\n\nExclusion Criteria:\n\n* scalp tumor or melanoma\n* having any serious mental illness or history, or taking psychotropic drugs\n* a medical history of dermatosis\n* severe liver and kidney damage\n* Pregnancy\n* Take any of the following medications for 6 months prior to initiation of the study: topical minoxidil, and spironolactone, and topical calcitriol\n* Receiving scalp cooling during chemotherapy'}, 'identificationModule': {'nctId': 'NCT05397457', 'briefTitle': 'Effect of Helmet Type, Home-use Low-level Light Therapy Device for Chemotherapy-induced Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Effect of Helmet Type, Home-use Photobiomodulation Therapy Device for Chemotherapy-induced Alopecia', 'orgStudyIdInfo': {'id': '202200395A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'interventionNames': ['Device: low-level light therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'low-level light therapy', 'type': 'DEVICE', 'description': 'Device: Hair Boom 69\n\nAll participants within the experimental group will undergo low-level light therapy sessions 3 times a week for the total duration of 4 weeks starting at their last CT administration.\n\nIf the participants can not cooperate to receive the therapy 3 times a week due to personal reasons, we will recommend that they undergo 2 courses of the therapy per week at least and finish the 12 courses of the intervention in 6 weeks.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20401', 'city': 'Keelung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'YUAN-CHIEH YEH, Assistant Professor', 'role': 'CONTACT', 'email': 'b9005030@gmail.com', 'phone': '(02)2431-3131', 'phoneExt': '2777'}], 'facility': 'Keelung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}], 'centralContacts': [{'name': 'YUAN-CHIEH YEH, Assistant Professor', 'role': 'CONTACT', 'email': 'b9005030@gmail.com', 'phone': '(02)2431-3131', 'phoneExt': '2777'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director, Assistant professor', 'investigatorFullName': 'YUAN-CHIEH YEH', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}