Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-15 @ 5:23 AM
Study NCT ID:
NCT02276404
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients
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': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presurgical psychological distress', 'timeFrame': 'expected average of 13 days', 'description': 'Measured by 100mm visual analog scale 1 day pre surgery'}, {'measure': 'postsurgical pain', 'timeFrame': 'expected average of 15 days', 'description': 'Measured by 100mm visual analog scale 1 day post surgery'}], 'secondaryOutcomes': [{'measure': 'postsurgical psychological distress', 'timeFrame': 'expected average of 15 days', 'description': 'Measured by 100mm visual analog scale 1 day post surgery'}, {'measure': 'postsurgical psychological distress', 'timeFrame': 'expected average of 21 days', 'description': 'Measured by 100mm visual analog scale 1 week post surgery'}, {'measure': 'postsurgical pain', 'timeFrame': 'expected average of 21 days', 'description': 'Measured by 100mm visual analog scale 1 week post surgery'}, {'measure': 'postsurgical nausea', 'timeFrame': 'expected average of 15 days', 'description': 'Measured by 100mm visual analog scale 1 day post surgery'}, {'measure': 'postsurgical nausea', 'timeFrame': 'expected average of 21 days', 'description': 'Measured by 100mm visual analog scale 1 week post surgery'}, {'measure': 'postsurgical fatigue', 'timeFrame': 'expected average of 15 days', 'description': 'Measured by 100mm visual analog scale 1 day post surgery'}, {'measure': 'postsurgical fatigue', 'timeFrame': 'expected average of 21 days', 'description': 'Measured by 100mm visual analog scale 1 week post surgery'}, {'measure': 'intraoperative analgesia use', 'timeFrame': 'expected average of 14 days', 'description': 'intraoperative analgesia use is taken from operative logs'}, {'measure': 'intraoperative anesthesia use', 'timeFrame': 'expected average of 14 days', 'description': 'intraoperative anesthesia use is taken from operative logs'}, {'measure': 'postoperative analgesia use', 'timeFrame': 'expected average of 15 days', 'description': 'postoperative analgesia use is taken from medical records'}, {'measure': 'immunemodulation', 'timeFrame': 'expected average of 14 days', 'description': 'natural killer cell activity is measured at begin of surgery'}, {'measure': 'immunemodulation', 'timeFrame': 'expected average of 14 days', 'description': 'natural killer cell activity is measured at end of surgery'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'expected average of 21 days', 'description': 'Number of patients with adverse events are measured one week post surgery'}, {'measure': 'presurgical psychological distress', 'timeFrame': 'expected average of 13 days', 'description': 'Measured by Profile of Mood States (POMS) 1 day pre surgery'}, {'measure': 'postsurgical psychological distress', 'timeFrame': 'expected average of 15 days', 'description': 'Measured by Profile of Mood States (POMS) 1 day post surgery'}, {'measure': 'postsurgical psychological distress', 'timeFrame': 'expected average of 21 days', 'description': 'Measured by Profile of Mood States (POMS) 1 week post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* clinically proven breast cancer with an indication for breast conserving surgery with max. 50% volume reduction\n* physical and psychological ability to take part in relaxation training\n\nExclusion criteria:\n\n* serious psychiatric disorder\n* to time span to surgery shorter than 2 weeks or longer than 20 weeks'}, 'identificationModule': {'nctId': 'NCT02276404', 'briefTitle': 'Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)', 'orgStudyIdInfo': {'id': '14-5778-BO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'relaxation training', 'description': 'Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.', 'interventionNames': ['Behavioral: relaxation training']}, {'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'description': 'Each participant of the experimental group 2 receives 3 acupuncture treatments with a semi-standardized acupoint scheme: once a week over 2 weeks and the day before surgery.', 'interventionNames': ['Other: acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'relaxation training and acupuncture', 'description': 'Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery.', 'interventionNames': ['Behavioral: relaxation training', 'Other: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'Patients receive usual senological treatment'}], 'interventions': [{'name': 'relaxation training', 'type': 'BEHAVIORAL', 'description': 'The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.', 'armGroupLabels': ['relaxation training', 'relaxation training and acupuncture']}, {'name': 'acupuncture', 'type': 'OTHER', 'description': 'The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.', 'armGroupLabels': ['acupuncture', 'relaxation training and acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Department of Senology, Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Gustav J. Dobos, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research fellow', 'investigatorFullName': 'Silke Lange', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}