Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:35 AM
Study NCT ID:
NCT07448558
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Exercise to Reduce Aromatase Inhibitor Associated Musculoskeletal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aromatase inhibitor associated musculoskeletal symptoms (AIMSS)', 'timeFrame': '12 months', 'description': 'occurrence of AIMSS'}], 'secondaryOutcomes': [{'measure': 'worsening pain', 'timeFrame': '12 months', 'description': 'reduce numerical scale of pain more than 2 points'}, {'measure': 'body weight', 'timeFrame': '12 months', 'description': 'body weight change'}, {'measure': 'quality of life FACT-ES', 'timeFrame': '12 months', 'description': 'FACT-ES score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'aromatase inhibitor', 'musculoskeletal associated symptoms', 'ิbreast cancer'], 'conditions': ['Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor']}, 'referencesModule': {'references': [{'pmid': '31853701', 'type': 'BACKGROUND', 'citation': 'Lu G, Zheng J, Zhang L. The effect of exercise on aromatase inhibitor-induced musculoskeletal symptoms in breast cancer survivors :a systematic review and meta-analysis. Support Care Cancer. 2020 Apr;28(4):1587-1596. doi: 10.1007/s00520-019-05186-1. Epub 2019 Dec 18.'}, {'pmid': '35005781', 'type': 'BACKGROUND', 'citation': 'Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.'}, {'pmid': '17922185', 'type': 'BACKGROUND', 'citation': 'Henry NL, Giles JT, Ang D, Mohan M, Dadabhoy D, Robarge J, Hayden J, Lemler S, Shahverdi K, Powers P, Li L, Flockhart D, Stearns V, Hayes DF, Storniolo AM, Clauw DJ. Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors. Breast Cancer Res Treat. 2008 Sep;111(2):365-72. doi: 10.1007/s10549-007-9774-6. Epub 2007 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled study evaluating effect of tailored exercise compared to routine practice as a preventive measure of aromatase inhibitor associated musculoskeletal related symptoms in early breast cancer patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer patients with starting adjuvant aromatase inhibitor within 4 weeks\n* able to read and write\n\nExclusion Criteria:\n\n* chronic arthritis\n* history of heart failure or acute coronary syndrome within 6 months\n* individuals who exercises regularly more than 150 minutes/week'}, 'identificationModule': {'nctId': 'NCT07448558', 'acronym': 'TAILOR-Ex', 'briefTitle': 'Tailored Exercise to Reduce Aromatase Inhibitor Associated Musculoskeletal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effectiveness of Tailored Home-based Exercise on Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitor: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '1171/2568(IRB3)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'routine practice'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tailored exercise', 'description': 'tailored exercise advise from sport scientist', 'interventionNames': ['Behavioral: tailored exercise']}], 'interventions': [{'name': 'tailored exercise', 'type': 'BEHAVIORAL', 'description': 'tailored suitable exercise to individuals recommended for the aim of aerobic exercise at 150 minutes per week and strengthening exercise twice a week', 'armGroupLabels': ['tailored exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suthinee Ithimakin', 'role': 'CONTACT', 'email': 'aesi105@yahoo.co.th', 'phone': '0898127440'}, {'role': 'CONTACT', 'email': 'aesi105@yahoo.co.th'}, {'name': 'Suthinee Ithimakin, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Suchaya Tanissa, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Concord Wongkraisri, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pisit Lertwanich, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suebwong Chutapisit, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Akarin Nimmannit, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kanchana Inthiraj', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Suthinee Ithimakin, M.D', 'role': 'CONTACT', 'email': 'aesi105@yahoo.co.th', 'phone': '+66898127440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'suthinee ithimakin', 'investigatorAffiliation': 'Siriraj Hospital'}}}}