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
In plain words A Phase 4 study of devil's Claw in female participants 18 and older, run by Hospices Civils de Lyon. It plans to enroll about 105 people at 3 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: Hormone Therapy-induced Arthralgia; Phytotherapy; Symptom Management; Adjuvant Treatment; Patient Acceptability; Joint Pain.
- Common Inclusion Criteria (applicable to both cohorts):
- 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),…
- Suffering from hormone therapy-induced arthralgia with a severity score of $\\ge 4/10$ on a numerical rating scale (NRS).
6 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant); Patient Experience Questionnaire
Registered 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. The full summary is on the listing.
Where, as registered
No US site; France (3).