Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05098951
Status:
UNKNOWN
Last Update Posted:
2021-11-10
First Post:
2021-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-09', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-10-17', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)', 'timeFrame': '6 weeks', 'description': 'The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline.'}], 'secondaryOutcomes': [{'measure': 'The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)', 'timeFrame': '6 weeks', 'description': 'The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) at the end of week 6 of intervention compared to that at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Stiffness', 'Aromatase inhibitor', 'Acupuncture', 'High altitude'], 'conditions': ['Breast Cancer', 'Stiffness of Hand, Not Elsewhere Classified']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Acupuncture may help relieve joint stiffness related to aromatase inhibitors in patients with early-stage breast cancer.\n\nPURPOSE: This single arm clinical study aims to evaluate how well acupuncture as a non-pharmacological treatment, works in treating patients with joint stiffness related to aromatase inhibitors (AIs) in patients with early-stage breast cancer.', 'detailedDescription': 'Objectives of this study:\n\nPrimary objective:\n\nTo evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6.\n\nSecondary objectives:\n\nTo evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12.\n\nTo evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12.\n\nTo evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12.\n\nTo evaluate the safety and tolerability of acupuncture in the enrolled patients.\n\nTo identify potential genetic determinants to response to acupuncture.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study just enroll female patients with breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of stage I-III breast cancer and free of disease by clinical examination\n2. Postmenopausal or premenopausal with ovarian suppression\n3. Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment\n4. With joint stiffness attributed to the use of aromatase inhibitors\n5. Having had joint stiffness for at least 1 months\n6. Having had at least 15 days with stiffness in the preceding 30 days\n\nExclusion Criteria:\n\n1. Women with recurrent or metastatic breast cancer\n2. Women having finished chemotherapy or radiation therapy less than 1 months prior to enrollment\n3. Women with history of bleeding disorder\n4. Women with joint stiffness attributed to inflammatory arthritis, such as rheumatoid arthritis, spondy loarthritis and osteoarthritis\n5. Women having joint stiffness prior to AI treatment\n6. Women that have received treatment of any kind for joint stiffness within the last 3 months\n7. Women that have previously received the acupuncture treatment before for any reason'}, 'identificationModule': {'nctId': 'NCT05098951', 'briefTitle': 'Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Qinghai University'}, 'officialTitle': 'Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer', 'orgStudyIdInfo': {'id': 'AHQU-2021004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with stiffness of joint receive acupuncture therapy', 'description': 'This is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks.', 'interventionNames': ['Device: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'DEVICE', 'description': 'Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.', 'armGroupLabels': ['Patients with stiffness of joint receive acupuncture therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '810000', 'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dengfeng Ren', 'role': 'CONTACT', 'email': 'dengfeng1104@126.com', 'phone': '+8613086297659'}], 'facility': 'Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}], 'centralContacts': [{'name': 'Dengfeng Ren', 'role': 'CONTACT', 'email': 'dengfeng1104@126.com', 'phone': '+8613086297659'}], 'overallOfficials': [{'name': 'Jiuda Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the Affiliated Hospital of Qinghai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Qinghai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jiuda Zhao', 'investigatorAffiliation': 'Affiliated Hospital of Qinghai University'}}}}