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Life sciences · Phase 4 Trial
ClinicalTrials.gov · November 3, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07859319). This is a study registration, not published results. Lead sponsor: Hospices Civils de Lyon. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 105 participants (ESTIMATED). Conditions: Hormone Therapy-induced Arthralgia, Phytotherapy, Symptom Management, Adjuvant Treatment, Patient Acceptability, Joint Pain. Interventions: DIETARY_SUPPLEMENT: Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant); OTHER: Patient Experience Questionnaire. Primary outcome measures: Change in joint pain score from baseline to day 21 , Baseline (Day 0) and Day 21 (+ 3 days). Brief summary: 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. However, 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. Current 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. In 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.