CBD for Joint Pain in Breast Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires that you continue taking your current aromatase inhibitor (AI) medication. However, you must stop using any cannabinoid products, certain pain medications, and other specific drugs like warfarin and some anti-epileptics before joining the study.
What evidence supports the effectiveness of the drug BRC-001, a CBD plant extract, for joint pain in breast cancer patients?
Research shows that CBD, a component of BRC-001, has been effective in reducing pain in cancer patients, particularly when combined with other treatments. Additionally, CBD has shown potential in enhancing the effects of chemotherapy drugs in breast cancer, suggesting it may help manage symptoms like joint pain.12345
How is the drug BRC-001 (CBD) different from other treatments for joint pain in breast cancer?
BRC-001, a plant extract of cannabidiol (CBD), is unique because it is derived from cannabis and may offer pain relief through its anti-inflammatory properties, unlike traditional pain medications that often rely on opioids or non-steroidal anti-inflammatory drugs (NSAIDs). This makes it a potentially safer option with fewer side effects for managing joint pain in breast cancer patients.678910
What is the purpose of this trial?
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.
Research Team
Lisa D Yee, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for women with breast cancer experiencing joint pain from aromatase inhibitors. Participants should be postmenopausal and currently on AI therapy. The study excludes those who have used cannabis products recently, are pregnant or breastfeeding, or have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BRC-001 or placebo orally twice daily for up to 3 months. Blood samples are collected during this phase.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, including assessment of adverse events.
Treatment Details
Interventions
- BRC-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Biopharmaceutical Research Company
Collaborator