Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 3:57 AM
Study NCT ID:
NCT04408560
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the score of "most intense pain" during the first 3 months of treatment with AI', 'timeFrame': '3 months', 'description': 'Evaluation comparing between the 2 groups the area under the most intense pain curve, measured each week during the first 3 months of AI treatment using the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort)'}], 'secondaryOutcomes': [{'measure': 'Evolution of joint pain', 'timeFrame': '6 months', 'description': 'variation of different pain scores on the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) : pain severity score corresponding to the average of the 4 questions on pain intensity, and interference score corresponding to the average of the 7 questions on the impact of pain'}, {'measure': 'Rate of onset of joint pain and stiffness', 'timeFrame': '3 months', 'description': 'For pain, among patients who answered "no" to the first question of Brief Pain Inventory-Short Form (1 no disconfort up to 10 complet disconfort) to visit 1, percentage of patients who answered "Yes" to 3 months (visit 2)'}, {'measure': 'Rate of onset of pain and joint stiffness', 'timeFrame': '3 months', 'description': 'Percentage of patients for whom pain and / or stiffness have occurred.'}, {'measure': 'Time of onset or aggravation of pain', 'timeFrame': '6 months', 'description': 'time from which the "most severe pain" score has increased for at least 2 consecutive weeks since the Visit 1 score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female', 'Joint Pain']}, 'descriptionModule': {'briefSummary': 'Interventional, randomised, prospective, monocentric study', 'detailedDescription': 'Interventional, randomised, prospective, monocentric study\n\nPrimary objective :\n\nDemonstrate the interest of the homeopathic Protocol to reduce the onset or aggravation of joint pain as a result of the taking of AI compared to conventional care\n\nSecondary objective :\n\nCompare between the two treatment groups:\n\n* Evolution of joint pain\n* Evolution of joint stiffness-rate of onset of pain and joint stiffness-delay in onset or aggravation of pain-evolution of the number of painful locations-evolution of the impact of pain on the quality of the sleep-consumption of permitted concomitant treatments (analgesics)\n* Evolution of symptoms of hormonal deprivation-adherence to AI treatment\n* Tolerance to AI\n* Change seen by patients\n* Stop rate and switch of AI-rate of recurrence of breast cancer\n\nDescribe in patients receiving homeopathic treatment:\n\n* Adherence to homeopathic treatment\n* Tolerance to homeopathic treatment\n* Group A: Group of patients receiving conventional treatment (drug analgesic class 1) for joint pain + homeopathic treatment\n* Group B: Group of patients receiving conventional treatment (drug analgesic class 1) for joint pain\n\nSchedule :\n\n* Inclusions start at: 01/09/2018\n* End date of inclusions: 01/09/2021\n* End date of follow-up: 23/03/2022\n* Study report: 23/03/2023'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* menopausal patient\n* achieved histologically confirmed non-metastatic breast cancer with positive hormonal receptors\n* starting an adjuvant anti-hormonal treatment with an AI\n* patient benefiting from a social protection scheme\n* patient mastering the French language -signature of free and informed consent -\n\nExclusion Criteria:\n\n* patient whose treatment with chemotherapy or radiotherapy is ongoing or anticipated during the theoretical period of the study or patient who has completed her chemotherapy treatment within a period of less than 4 weeks prior to the inclusion visit\n* patient with proven inflammatory rheumatism already diagnosed with rheumatoid arthritis, lupus, psoriatic rheumatism, ankylosing spondylitis -concomitant treatment with other complementary medicines (excepted Vitamin D), unless the treatment has been stable for at least 1 month.\n* current treatment with narcotic drugs or corticosteroids\n* patient with overexpressing breast cancer HER2'}, 'identificationModule': {'nctId': 'NCT04408560', 'acronym': 'ARHOMA2', 'briefTitle': 'Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Jean-Godinot'}, 'officialTitle': 'Evaluation of the Efficacy of a Homeopathic Protocol to Reduce the Onset or Aggravation of Joint Pain or Stiffness Following the Taking of Anti-aromatases (AI) in Patients With Non-metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '2018-A01019-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Groupe A with homéopathic treatment', 'description': 'Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH', 'interventionNames': ['Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)', 'Other: paracetamol (drug analgesic class1)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Groupe B without homeopathic treatment', 'description': 'Conventional treatment : paracetamol (drug analgesic class1)', 'interventionNames': ['Other: paracetamol (drug analgesic class1)']}], 'interventions': [{'name': 'Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)', 'type': 'DRUG', 'description': 'Rhus toxicodendron 9 CH + Ruta graveolens 5 CH', 'armGroupLabels': ['Groupe A with homéopathic treatment']}, {'name': 'paracetamol (drug analgesic class1)', 'type': 'OTHER', 'description': 'paracetamol (drug analgesic class1)', 'armGroupLabels': ['Groupe A with homéopathic treatment', 'Groupe B without homeopathic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Philippe GUILBERT', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'overallOfficials': [{'name': 'PHILIPPE GUILBERT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Jean-Godinot'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Jean-Godinot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}