A Phase 4 interventional study of Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant) and Patient Experience Questionnaire in Hormone Therapy-induced Arthralgia, Phytotherapy and Symptom Management, sponsored by Hospices Civils de Lyon. Not yet recruiting at 3 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Hospices Civils de Lyon · Phase 4, Interventional, and Supportive care
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.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's planned enrollment of 105 is above the median of 63 across 219 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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/female condoms, surgical methods like bilateral tubal ligation, or true abstinence).
Affiliated with or a beneficiary of a social security regime.
Exclusion Criteria:
Concurrent participation in another clinical, drug, or cosmetic research study.
Patients in the interventional arm receive a daily oral herbal dietary supplement combining Devil's claw (Harpagophytum procumbens), Meadowsweet (Filipendula ulmaria), and Blackcurrant (Ribes nigrum). The intervention is administered in a capsule dosage form at a dose of 2 capsules twice daily (totaling 4 capsules per day) for a duration of 21 consecutive days. This supportive care treatment is taken concomitantly with the patient's ongoing, standard adjuvant hormone therapy (tamoxifen, aromatase inhibitors, or LH-RH analogues) to evaluate its efficacy in managing hormone therapy-induced arthralgia.
Dietary Supplement: Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant) · Other: Patient Experience Questionnaire
Patients in the external control group receive standard of care management for their hormone therapy-induced arthralgia, with no experimental phytotherapeutic intervention administered. Data regarding their joint pain are collected from routine clinical practice medical records, including a baseline numerical pain rating scale assessment (Day 0) and a follow-up assessment conducted by telephone at Day 21 (+ 3 days) during routine oncology follow-up. This group is matched with the interventional cohort based on clinical criteria such as age, hormone therapy type, and treatment line.
Administration of an oral herbal dietary supplement combining Devil's claw (Harpagophytum procumbens), Meadowsweet (Filipendula ulmaria), and Blackcurrant (Ribes nigrum). The product is provided in capsule dosage form at a dose of 2 capsules twice daily (4 capsules per day) for a duration of 21 consecutive days, taken concomitantly with the patient's ongoing adjuvant hormone therapy to manage joint pain.
Administration of an ad hoc questionnaire utilizing Likert scales, conducted via telephone interview at Day 21. This tool evaluates the patient's feedback on three key implementation dimensions based on Proctor's framework: acceptability (overall perception, perceived satisfaction, and encountered difficulties), appropriateness (perceived relevance and suitability of the intervention), and feasibility.
Change in joint pain score from baseline to day 21
Joint pain intensity is self-reported by the patient using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." The primary outcome is calculated as the change in the NRS score from baseline (Day 0) to Day 21, comparing the interventional group with the matched external control group.
Time frame: Baseline (Day 0) and Day 21 (+ 3 days)
Change in analgesic medication consumption
Patient self-reported consumption of analgesic treatments (paracetamol, non-steroidal anti-inflammatory drugs, tramadol, codeine-containing paracetamol, morphine sulfate, or oxycodone) recorded prospectively via a daily tracking diary during the first week (Day 0 to Day 7) and the final week (Day 14 to Day 21) of the study period.
Time frame: Daily tracking during the first week (Day 0 to Day 7) and final week (Day 14 to Day 21) of the 21-day intervention period
Incidence and severity of adverse events (Tolerance)
Assessment of adverse events and treatment safety evaluated through patient reporting in the study diary and clinical monitoring throughout the intervention period. Toxicity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6.0).
Time frame: Throughout the intervention and follow-up period, from Day 0 up to Day 28 (+ 3 days)
Patient experience assessment: acceptability, appropriateness, and feasibility
Evaluation of the patient's feedback regarding the phytotherapy dietary supplement using an ad hoc questionnaire with Likert scales based on Proctor's implementation framework. The questionnaire assesses three core dimensions: acceptability (overall perception, satisfaction, and difficulties encountered), appropriateness (perceived relevance and suitability of the intervention), and feasibility.
Time frame: Day 21 (+ 3 days) via telephone interview
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hospices Civils de Lyon