Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT05762250
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020831', 'term': 'Acupuncture, Ear'}], 'ancestors': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055097', 'term': 'Auriculotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in disease-specific quality of life (FACT-MM)', 'timeFrame': 'after 8 weeks (end of intervention)', 'description': "The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself.\n\nThe diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study."}], 'secondaryOutcomes': [{'measure': 'Change in anxiety and depressiveness', 'timeFrame': 'fourth week of intervention', 'description': 'The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.'}, {'measure': 'Change in anxiety and depressiveness', 'timeFrame': 'after 8 weeks (end of intervention)', 'description': 'The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.'}, {'measure': 'Change in anxiety and depressiveness', 'timeFrame': '2 weeks post-intervention', 'description': 'The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.'}, {'measure': 'Change in anxiety and depressiveness', 'timeFrame': '12 weeks post-intervention', 'description': 'The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.'}, {'measure': 'Change of individual symptom burden', 'timeFrame': 'fourth week of intervention', 'description': 'Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.'}, {'measure': 'Change of individual symptom burden', 'timeFrame': 'after 8 weeks (end of intervention)', 'description': 'Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.'}, {'measure': 'Change of pain', 'timeFrame': 'fourth week of intervention', 'description': 'Improvement of pain (FACT-MM) questionnaire'}, {'measure': 'Change of pain', 'timeFrame': 'after 8 weeks (end of intervention)', 'description': 'Improvement of pain (FACT-MM) questionnaire'}, {'measure': 'Change of pain', 'timeFrame': '2 weeks post-intervention', 'description': 'Improvement of pain (FACT-MM) questionnaire'}, {'measure': 'Change of pain', 'timeFrame': '12 weeks post-intervention', 'description': 'Improvement of pain (FACT-MM) questionnaire'}, {'measure': 'Change of Fatigue', 'timeFrame': 'fourth week of intervention', 'description': 'The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.'}, {'measure': 'Change of Fatigue', 'timeFrame': 'after 8 weeks (end of intervention)', 'description': 'The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.'}, {'measure': 'Change of Fatigue', 'timeFrame': '2 weeks post-intervention', 'description': 'The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.'}, {'measure': 'Change of Fatigue', 'timeFrame': '12 weeks post-intervention', 'description': 'The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.'}, {'measure': 'Change of sleep disorders and sleep quality', 'timeFrame': 'fourth week of intervention', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval'}, {'measure': 'Change of sleep disorders and sleep quality', 'timeFrame': 'after 8 weeks (end of intervention)', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval'}, {'measure': 'Change of sleep disorders and sleep quality', 'timeFrame': '2 weeks post-intervention', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval'}, {'measure': 'Change of sleep disorders and sleep quality', 'timeFrame': '12 weeks post-intervention', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval'}, {'measure': 'Number of pateints with adverse events', 'timeFrame': 'through study completion, an average of 3 Years', 'description': 'Tolerability of the application'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Auricular Acupuncture', 'advanced tumour diseases'], 'conditions': ['Fatigue', 'Pain', 'Depression', 'Advanced Tumour Diseases']}, 'descriptionModule': {'briefSummary': 'In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with advanced tumour diseases. (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with advanced tumour diseases on current therapy, who suffer from persistent disease- or therapy-associated symptoms and limitations (screening by distress thermometer, score ≥ 5)\n* Informed consent.\n\nExclusion Criteria:\n\n* medical reasons or\n* a mental condition which, in the opinion of the investigator, does not allow the patient to participate in the study,\n* a planned radiation therapy in the area of the skull (to avoid potential scattered radiation),\n* a missing legally binding signature on the informed consent form,\n* participation in another acupuncture/acupressure study.'}, 'identificationModule': {'nctId': 'NCT05762250', 'acronym': 'MY_ACU', 'briefTitle': 'Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'S00776'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auricular Acupuncture', 'description': 'Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided).\n\nIn addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence.', 'interventionNames': ['Other: Auricular Acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline.'}], 'interventions': [{'name': 'Auricular Acupuncture', 'type': 'OTHER', 'description': "Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).", 'armGroupLabels': ['Auricular Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcela Winkler, MD', 'role': 'CONTACT'}], 'facility': 'Robert Bosch Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Claudia Loeffler, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Claudia Loeffler, Dr', 'role': 'CONTACT', 'email': 'loeffler_C@ukw.de', 'phone': '+49 93120144966'}], 'overallOfficials': [{'name': 'Claudia Loeffler, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Wuerzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}