Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-29 @ 1:30 AM
Study NCT ID:
NCT06331793
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization 1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '72 hours', 'description': 'Difference in mean NRS score between the two arms, at 24 hours and 72 hours after surgery (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Need for analgesic drugs', 'timeFrame': '3 months', 'description': 'Compare analgesic drugs use between the two arms'}, {'measure': 'Patient reported pain characteristics', 'timeFrame': '3 months', 'description': 'Compare characteristics of pain between the two arms by collection of a questionnaire that describes kind of pain experienced by patient'}, {'measure': 'Number of participants with other symptoms', 'timeFrame': '3 months', 'description': 'Compare presence of other symptoms between the two arms by collection of a questionnarie in which patient reports occurence of nausea, vomiting or other symptoms'}, {'measure': 'Need for other drugs', 'timeFrame': '3 months', 'description': 'Compare use of drugs (other than analgesic ones) between the two arms'}, {'measure': 'Wound healing timing', 'timeFrame': '3 months', 'description': 'Compare days needed to complete wound healing between the two arms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unilateral mastectomy with reconstruction', 'Post Operative Pain'], 'conditions': ['Female Breast Cancer', 'Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs.', 'detailedDescription': "The treatment of postoperative pain is a priority issue for both the doctor and the patient. Obtaining adequate analgesia in the first postoperative days, in fact, is essential for the patient's comfort, but also to promote and accelerate functional recovery and prevent chronic pain, which in the case of breast surgery has a high incidence (20-60 %).\n\nThe use of pulsed electromagnetic fields (PEMF) for the treatment of pain and inflammation has been widely studied and validated.\n\nStudy aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields), for the treatment of postoperative pain in oncological breast surgery. This is a field of application in which this technique analgesic has never been tested, but in which it could prove valid within a multimodal analgesia protocol, as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound. AlgoCare is a non-invasive and non-pharmacological device, developed specifically for treatment of post-operative inflammation and pain, CE certified and registered with the Ministry of Health. It emits a pulsed radio frequency electromagnetic field at 27.1 MHz, a frequency already studied and approved for medical use."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection\n\nExclusion Criteria:\n\n* Patients with PaceMakers (PMs), Implantable Cardioverter Defibrillators (ICDs), neurostimulators or other active medical devices or metal implants near the application area\n* Pregnancy\n* Amyloidosis, sarcoidosis, scleroderma, infectious arthritis, Paget's disease or joint tumors"}, 'identificationModule': {'nctId': 'NCT06331793', 'acronym': 'Algocare', 'briefTitle': 'Pulsed Electromagnetic Fields for Analgesia Post Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies', 'orgStudyIdInfo': {'id': 'IEO 1849'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active AlgoCare', 'description': 'An active AlgoCare device (that emits a pulsed radio frequency electromagnetic field at 27.1 MHz) will be placed over the surgical dressing using a plaster or bandage for six days.', 'interventionNames': ['Device: Active AlgoCare']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-active AlgoCare', 'description': "A non-active AlgoCare device (that doesn't emit pulsed radio frequency electromagnetic field) will be placed over the surgical dressing using a plaster or bandage for six days.", 'interventionNames': ['Device: Non-active AlgoCare']}], 'interventions': [{'name': 'Active AlgoCare', 'type': 'DEVICE', 'description': 'Device that emits Pulsed Electromagnetic Fields', 'armGroupLabels': ['Active AlgoCare']}, {'name': 'Non-active AlgoCare', 'type': 'DEVICE', 'description': "Device that doesn't emit Pulsed Electromagnetic Fields", 'armGroupLabels': ['Non-active AlgoCare']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Sances, MD', 'role': 'CONTACT', 'email': 'daniele.sances@ieo.it', 'phone': '+390257489618'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Daniele Sances, MD', 'role': 'CONTACT', 'email': 'daniele.sances@ieo.it', 'phone': '+390257489618'}], 'overallOfficials': [{'name': 'Daniele Sances, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}