[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608284":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":34,"collaborators":20,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":20,"maxAge":20,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":20,"overallStatus":54,"whyStopped":20,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},{"fullName":5,"class":6},"Arafarma Group, S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","There is only one arm in the study. All patients will be treated with the experimental food supplement.",[13],"Dietary Supplement: Food supplement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Food supplement","Tenflex® is an authorized food supplement.",[9],null,[22],{"facility":23,"status":20,"city":24,"state":20,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":20},"Hospital Clínic Barcelona","Barcelona","08036","Spain","ES",{"type":29,"coordinates":30},"Point",[31,32],2.15899,41.38879,{"lat":32,"lon":31},{"type":35,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100608284","impact-of-a-food-supplement-on-musculoskeletal-pain-in-women-with-breast-cancer-treated-with-aromatase-inhibitors-100608284",false,"NCT07199556","Impact of a Food Supplement on Musculoskeletal Pain in Women With Breast Cancer Treated With Aromatase Inhibitors.","Study of the Impact of a Nutraceutical on Pain in Women With Musculoskeletal Symptoms Associated With Hormonal Therapy With Aromatase Inhibitors, in ER and\u002For PgR Positive Breast Cancer, After Antitumor Therapy.","DOLFLEX","Inclusion Criteria:\n\n* Women with histologically confirmed hormone receptor-positive breast carcinoma, without evidence of metastatic disease (M0).\n* Surgical treatment completed and any surgery-related complications resolved.\n* Currently receiving hormonal therapy with aromatase inhibitors (AIs) for at least 21 days, with pain symptoms lasting less than 6 months attributable to AIs, and with a treatment plan to continue for at least an additional 180 days (6 months).\n* Musculoskeletal symptoms associated with hormonal therapy that began or worsened after initiation of such therapy. New musculoskeletal pain must not be specifically due to fractures or traumatic injuries.\n* \"Average pain\" score of at least 4, as assessed by the mBPI-sf questionnaire within 7 days prior to enrollment or baseline visit.\n* ECOG performance status of 0-2.\n* Patients able to provide informed consent.\n\nExclusion Criteria:\n\n* Concurrent medical or arthritic conditions that may confound or interfere with the assessment of pain or efficacy, such as rheumatologic\u002Finflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) or cancer that may affect bone.\n* Chemotherapy and\u002For radiotherapy completed within 28 days prior to enrollment or baseline visit, and\u002For unresolved Grade ≥2 side effects related to chemotherapy and\u002For radiotherapy, except for alopecia and peripheral neuropathy.\n* Known allergy or hypersensitivity to Tenflex®.\n* Pregnant or breastfeeding patients.","FEMALE",{"count":46,"type":47},30,"ACTUAL","INTERVENTIONAL",[50],"NA","The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks. The collagen- and chondroitin sulfate-based food supplement may help improve pain in these patients with musculoskeletal symptoms associated with hormone therapy in ER- and\u002For PR-positive breast cancer.",[53],"Breast Cancer","COMPLETED","2025-09-30",{"date":57,"type":47},"2025-10-03",{"date":59,"type":47},"2024-03-14",{"date":61,"type":47},"2025-09-10",{"name":5,"class":6},1]