[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-therapy-induced-arthralgia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-therapy-induced-arthralgia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100659041","phase-4-evaluation-of-the-efficacy-and-acceptability-of-a-phytotherapy-combining-devils-claw-blackcurrant-and-meadowsweet-for-the-management-of-aromatase-inhibitor-induced-arthralgia-in-patients-treated-for-localized-breast-cancer-in-the-adjuvant-setting-100659041",false,"NCT07859319","Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting","ERABLE","Inclusion Criteria:\n\n• Common Inclusion Criteria (applicable to both cohorts):\n\n1. Age 18 years or older.\n2. Histologically or clinically confirmed localized breast cancer treated for at least 3 months with adjuvant hormone therapy according to standard clinical practices: selective estrogen receptor modulators (SERMs, e.g., tamoxifen alone), aromatase inhibitors (AIs, e.g., anastrozole, letrozole, or exemestane alone), or in combination with an LH-RH agonist (goserelin or leuprorelin). Concomitant targeted therapy with ribociclib or abemaciclib is permitted.\n3. Suffering from hormone therapy-induced arthralgia with a severity score of $\\\\ge 4\u002F10$ on a numerical rating scale (NRS).\n4. For women of childbearing potential: use of a highly effective contraception method throughout the study duration (excluding hormonal options, prioritizing mechanical methods such as a copper intrauterine device, male\u002Ffemale condoms, surgical methods like bilateral tubal ligation, or true abstinence).\n\n   • Specific Inclusion Criteria for the Interventional Cohort:\n5. Provided signed and dated written informed consent.\n6. Affiliated with or a beneficiary of a social security regime.\n\n   • Specific Selection Criteria for the External Control Group:\n7. Availability of necessary clinical data required for the primary outcome evaluation (joint pain assessment at baseline\u002FDay 0 and Day 21 $\\\\pm 3$ days).\n\nExclusion Criteria:\n\n• Specific Exclusion Criteria for the Interventional Cohort:\n\n1. Presence of medical conditions contraindicating the active ingredients of the dietary supplement: active gastroduodenal ulcer, biliary disorders (gallstones), uncontrolled heart failure, or edematous renal failure.\n2. Known allergy or hypersensitivity to any of the components of the dietary supplement (blackcurrant, meadowsweet, excipients, etc.).\n3. Hypersensitivity to salicylates.\n4. Pregnant or breastfeeding women.\n5. Persons deprived of liberty or under legal guardianship\u002Fprotection.\n6. Inability to complete the study diary during the follow-up period based on the investigator's judgment (e.g., non-French speaking\u002Fallophone, dementia).\n7. Impossibility to comply with the medical follow-up of the study for geographical, social, or psychological reasons.\n8. Concurrent participation in another clinical, drug, or cosmetic research study.\n\n   • Specific Non-Selection Criteria for the External Control Group:\n9. Patient objection or refusal regarding the reuse of their medical data for research purposes.","FEMALE","18 Years",{"count":19,"type":20},105,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Adjuvant hormonotherapy is a cornerstone of treatment for localized hormone receptor-positive (HR+) breast cancer, accounting for approximately 80% of patients. The main classes used are selective estrogen receptor modulators (SERMs, including tamoxifen) and aromatase inhibitors (anastrozole, letrozole, exemestane), with or without LH-RH agonists (leuprorelin, goserelin), administered daily for 5 to 8 years.\n\nHowever, these treatments are frequently associated with adverse events, predominantly musculoskeletal disorders such as arthralgia, which can significantly impair quality of life. These symptoms cause functional impact and promote premature discontinuation of treatment, thereby compromising therapeutic adherence and increasing the risk of tumor relapse.\n\nCurrent management strategies for these arthralgias, whether pharmacological or non-pharmacological, show limited efficacy or insufficient levels of evidence, with the exception of certain approaches like acupuncture. In the absence of satisfactory solutions, many patients turn to alternative medicines, notably phytotherapy. However, these practices raise safety concerns (drug interactions, misuse) and rely on limited scientific evidence, especially since they are often underreported to healthcare professionals.\n\nIn this context, there is a clear need to rigorously evaluate new therapeutic approaches. The non-randomized ERABLE study aims to explore the efficacy and acceptability of a phytotherapy selected for its analgesic properties on hormone therapy-induced arthralgia in patients treated for localized breast cancer. If positive, this study will be followed by a randomized trial to confirm efficacy and achieve a level of evidence compatible with clinical guidelines.",[26,27,28,29,30,31],"Hormone Therapy-induced Arthralgia","Phytotherapy","Symptom Management","Adjuvant Treatment","Patient Acceptability","Joint Pain",[33,34,35,27,36],"Breast cancer","Adjuvant treatment","Hormone therapy-induced arthralgia","Quality of life","NOT_YET_RECRUITING","2026-09-29",{"date":40,"type":41},"2026-10-05","ACTUAL",{"date":43,"type":20},"2027-01",{"date":45,"type":20},"2028-03",{"name":47,"class":48},"Hospices Civils de Lyon","OTHER",3]