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)
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Gilles FREYER, Pr
- 電話番号：+33 04 78 86 43 18
- メール：gilles.freyer@chu-lyon.fr
研究連絡先のバックアップ
- 名前：Angelique STUANI
- 電話番号：+33 04 78 86 23 76
- メール：angelique.stuani@chu-lyon.fr
研究場所
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Bron、フランス
- Oncology Unit, Hospices Civils de Lyon Est
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コンタクト：
- Marie BEGUINOT, PU, MD
- 電話番号：+33 04 72 35 58 85
- メール：marie.beguinot@chu-lyon.fr
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主任研究者：
- Marie BEGUINOT, PU, MD
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Lyon、フランス
- Oncology Unit, Hospices Civils de Lyon Nord
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コンタクト：
- Eva KALFALA, PU, MD
- 電話番号：+33 04 26 73 26 12
- メール：Eva.kalfala@chu-lyon.fr
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主任研究者：
- Eva KALFALA, PU, MD
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Pierre-Bénite、フランス
- Oncology Unit, Hospices Civils de Lyon Sud
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コンタクト：
- Gilles FREYER, PU-PH
- 電話番号：+33 04 78 86 43 18
- メール：gilles.freyer@chu-lyon.fr
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主任研究者：
- Gilles FREYER, PU-PH
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
• Common Inclusion Criteria (applicable to both cohorts):
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Age 18 years or older.
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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.
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Suffering from hormone therapy-induced arthralgia with a severity score of $\ge 4/10$ on a numerical rating scale (NRS).
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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).
• Specific Inclusion Criteria for the Interventional Cohort:
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Provided signed and dated written informed consent.
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Affiliated with or a beneficiary of a social security regime.
• Specific Selection Criteria for the External Control Group:
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Availability of necessary clinical data required for the primary outcome evaluation (joint pain assessment at baseline/Day 0 and Day 21 $\pm 3$ days).
Exclusion Criteria:
• Specific Exclusion Criteria for the Interventional Cohort:
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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.
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Known allergy or hypersensitivity to any of the components of the dietary supplement (blackcurrant, meadowsweet, excipients, etc.).
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Hypersensitivity to salicylates.
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Pregnant or breastfeeding women.
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Persons deprived of liberty or under legal guardianship/protection.
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Inability to complete the study diary during the follow-up period based on the investigator's judgment (e.g., non-French speaking/allophone, dementia).
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Impossibility to comply with the medical follow-up of the study for geographical, social, or psychological reasons.
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Concurrent participation in another clinical, drug, or cosmetic research study.
• Specific Non-Selection Criteria for the External Control Group:
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Patient objection or refusal regarding the reuse of their medical data for research purposes.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Herbal dietary supplement group (interventional group)
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. |
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. |
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介入なし：Standard of care (External control)
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in joint pain score from baseline to day 21
時間枠：Baseline (Day 0) and Day 21 (+ 3 days)
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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. |
Baseline (Day 0) and Day 21 (+ 3 days)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in analgesic medication consumption
時間枠：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
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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. |
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
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Incidence and severity of adverse events (Tolerance)
時間枠：Throughout the intervention and follow-up period, from Day 0 up to Day 28 (+ 3 days)
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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). |
Throughout the intervention and follow-up period, from Day 0 up to Day 28 (+ 3 days)
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Patient experience assessment: acceptability, appropriateness, and feasibility
時間枠：Day 21 (+ 3 days) via telephone interview
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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. |
Day 21 (+ 3 days) via telephone interview
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。