Clareo Health | 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
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
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).
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).
You may not be if
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.
