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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

ConditionsHormone Therapy-induced ArthralgiaPhytotherapySymptom ManagementAdjuvant TreatmentPatient AcceptabilityJoint Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

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.

Suffering from hormone therapy-induced arthralgia with a severity score of $\ge 4/10$ on a numerical rating scale (NRS).

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).

Disqualifiers

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.

Known allergy or hypersensitivity to any of the components of the dietary supplement (blackcurrant, meadowsweet, excipients, etc.).

Hypersensitivity to salicylates.

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant)

    Dietary supplement

    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.

  • Patient Experience Questionnaire

    Other intervention

    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.

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Herbal dietary supplement group (interventional group)Experimental treatment 2 interventions
Group B: Standard of care (External control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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)
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

IPHYM

Collaborator

Source ClinicalTrials.gov

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