Actively Recruiting
High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer - A Randomized Controlled Double Blind Clinical Trial
Led by City of Hope Medical Center · Updated on 2026-04-30
36
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of cannabidiol (CBD) plant extract (BRC-001) on joint stiffness and pain in women with breast cancer who are taking aromatase inhibitors (AIs). Aromatase inhibitors lower estrogen levels in postmenopausal women to reduce breast cancer recurrence but can cause joint pain and stiffness, leading some women to stop treatment early. This phase II trial aims to understand whether BRC-001 can help reduce these symptoms without causing a "high" or addiction. Participants are randomly assigned to one of two groups. One group receives BRC-001 orally twice daily, starting at 200 mg daily and increasing up to 800 mg daily over two weeks based on tolerance, for up to three months. The other group receives a placebo on the same schedule. Blood samples are collected during the study to assess biological effects, and participants are followed up 30 days after treatment ends. During the trial, women complete questionnaires about pain, anxiety, sleep, and quality of life. Researchers measure physical function through grip strength and monitor safety with lab tests for liver function and other health indicators. The main outcome is change in worst pain severity over three months. The study also evaluates joint symptoms, side effects, anxiety, sleep disturbance, and blood markers related to joint pain. Participation lasts for about four months including follow-up.
CONDITIONS
Brief 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
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Postmenopausal by last menstrual period over 12 months or medically induced menopause
- At least 5 years since other malignancy except certain treated skin or cervical cancers
- Ability to read and understand English, Spanish, or use interpreter translations
- Histologically confirmed primary invasive breast adenocarcinoma or ductal carcinoma in situ, Stage 0, I, II, or IIIA with no metastatic disease
- Completed definitive breast cancer surgery and recovered
- Completed adjuvant chemotherapy, anti-HER2 therapy, and/or radiation as applicable
- 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 Brief Pain Inventory that started or increased with AI therapy
You will not qualify if you...
- Use of cannabinoid or cannabis products within 3 months prior to registration
- Use of investigational agents within 28 days prior to registration
- Medical, alternative, or physical therapy for joint pain within 30 days prior to registration
- Narcotic use within 14 days prior to registration
- Oral or intramuscular corticosteroids within 28 days prior to registration
- Intra-articular steroid injections within 28 days prior to registration
- Use of topical analgesics or analgesics other than NSAIDs or acetaminophen within 14 days prior to registration
- History of bone fracture or surgery in affected joints within 6 months prior to registration
- Uncontrolled illness or active infection
- Known allergies or contraindications to cannabis
- Significant liver or kidney impairment based on lab tests
- Clinically significant lab abnormalities preventing safe participation
- Current suicidal thoughts or history of suicide attempts
- Major psychiatric illness such as bipolar disorder, major depression, or psychosis
- History of seizure disorder
- Use of medications that may interact adversely with CBD
- Concurrent use of cyclin-dependent kinase 4/6 inhibitors with AI therapy
- Any physical abnormalities preventing safe participation
- Other active malignancies
- Conditions or medications that contraindicate participation due to safety concerns
- Unwillingness to abstain from blood donation during the study
- Plans to travel outside the United States during the study
- Women with childbearing potential
- Cognitive impairment affecting ability to comply with study procedures
- Inability to comply with all study procedures due to logistical or feasibility issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive either BRC-001 or placebo by mouth twice daily for up to 3 months. During this time, blood samples are collected to monitor safety and study effects.
Regular visits for dosing and assessments including blood sample collection
Duration - 30 days
Participants are followed for safety and adverse events after completing treatment.
1 follow-up visit (in-person)
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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