Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07859319

PHASE4

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

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2027-01

Completion Date

2028-03

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Hormone Therapy-induced Arthralgia Phytotherapy Symptom Management Adjuvant Treatment Patient Acceptability Joint Pain

Interventions

DIETARY_SUPPLEMENT

Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant)

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.

OTHER

Patient Experience Questionnaire

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.

Inclusion Criteria: • Common Inclusion Criteria (applicable to both cohorts): 1. Age 18 years or older. 2. 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. 3. Suffering from hormone therapy-induced arthralgia with a severity score of $\\ge 4/10$ on a numerical rating scale (NRS). 4. 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: 5. Provided signed and dated written informed consent. 6. Affiliated with or a beneficiary of a social security regime. • Specific Selection Criteria for the External Control Group: 7. 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: 1. 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. 2. Known allergy or hypersensitivity to any of the components of the dietary supplement (blackcurrant, meadowsweet, excipients, etc.). 3. Hypersensitivity to salicylates. 4. Pregnant or breastfeeding women. 5. Persons deprived of liberty or under legal guardianship/protection. 6. Inability to complete the study diary during the follow-up period based on the investigator's judgment (e.g., non-French speaking/allophone, dementia). 7. Impossibility to comply with the medical follow-up of the study for geographical, social, or psychological reasons. 8. Concurrent participation in another clinical, drug, or cosmetic research study. • Specific Non-Selection Criteria for the External Control Group: 9. Patient objection or refusal regarding the reuse of their medical data for research purposes.

Locations (3)

Oncology Unit, Hospices Civils de Lyon Est

Bron, France

Oncology Unit, Hospices Civils de Lyon Nord

Lyon, France

Oncology Unit, Hospices Civils de Lyon Sud

Pierre-Bénite, France