Actively Recruiting
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
Led by City of Hope Medical Center · Updated on 2026-04-30
36
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent to participate
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Postmenopausal by last menstrual period over 12 months ago or medically induced menopause for AI therapy
- At least 5 years since any other cancer except certain treated skin or cervical cancers
- Able to read and understand English, Spanish, or have interpreter assistance for questionnaires
- Histologically confirmed primary invasive breast adenocarcinoma or ductal carcinoma in situ, stages 0, I, II, or IIIA with no metastatic disease
- Completed breast cancer surgery and recovered
- Completed any applicable chemotherapy, anti-HER2, and/or radiation therapy
- Estrogen receptor-positive and/or progesterone receptor-positive breast cancer
- Currently taking a third-generation aromatase inhibitor for at least 90 days with plans to continue for at least 180 days
- Worst joint pain or stiffness score of 4 or higher on the Brief Pain Inventory that started or increased with AI therapy
You will not qualify if you...
- Used cannabinoid products including CBD, THC, Marinol, or Epidiolex within the past 3 months or unwilling to abstain during the study
- Received investigational agents within the past 28 days
- Received medical, alternative, or physical therapy for joint pain/stiffness within the past 30 days
- Used narcotics within 14 days before registration
- Received oral or intramuscular corticosteroids within 28 days before registration
- Received intra-articular steroids in any joint within 28 days before registration
- Used topical analgesics or certain other analgesics (except NSAIDs or acetaminophen) within 14 days before registration
- Had bone fracture or surgery of affected joints within 6 months before registration
- Have uncontrolled illnesses or active infections
- Have allergies or contraindications to cannabis
- Have significantly impaired liver function or grade 3+ kidney impairment
- Have clinically significant lab abnormalities that would prevent safe participation
- Have current or past suicidal thoughts or major psychiatric illness
- History of seizure disorder
- Taking medications that may interact adversely with CBD
- Taking cyclin-dependent kinase 4/6 inhibitors with AI therapy
- Physical exam abnormalities preventing safe participation
- Have other active cancers
- Any condition or medication use that contraindicates study participation
- Unwilling to abstain from blood donation during the study
- Plan to travel outside the United States during the study
- Women who are not postmenopausal
- Have cognitive impairment preventing compliance
- Unable to comply with study procedures due to feasibility or logistics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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