High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
Trial Parameters
Brief Summary
This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a "high" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.
Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Postmenopausal by last menses \> 12 months or medically induced menopause in premenopausal women for AI therapy use * At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission * Ability to read and understand English, Spanish, or translations by interpreters for questionnaires * Histologically confirmed primary invasive adenocarcinoma of the breast or ductal carcinoma in situ of the breast * Stage 0, I, II, or IIIA disease * No metastatic disease * Must have undergone definitive breast cancer surgery and recovered * Must have completed adjuvant chemotherapy as applicable, including systemic chemotherapy, anti-HER2 therapy, and/or radiation therapy * Estrogen-receptor positive (ER