High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial
City of Hope Medical Center
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.
Description
PRIMARY OBJECTIVE: I. To assess the preliminary efficacy of BRC-001 versus placebo by change in Brief Pain Inventory-Short Form (BPI-SF) worst pain severity scores from 0 to 3 months. SECONDARY OBJECTIVES: I. To evaluate indicators of preliminary efficacy of BRC-001 on joint symptoms of pain and stiffness assessed by BPI-SF total pain severity and total pain interference scores and Visual Analog Scale-Pain. II. To evaluate tolerability by adverse events, anxiety by Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form (SF) 6a, sleep by PROM…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 * Histolo…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugBRC-001
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- City of Hope Medical CenterDuarte, California