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.
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 PROMIS Sleep Disturbance SF 4a, quality of life by Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES). III. To evaluate safety by clinical laboratory tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], total bilirubin). IV. To evaluate changes in physical function by dynamometer measurements of grip strength. EXPLORATORY OBJECTIVES: I. To evaluate blood-based biomarkers related to aromatase inhibitor-induced arthralgia (AIIA) and BRC-001 versus (vs) placebo. II. Pharmacokinetics of BRC-001. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive BRC-001 orally (PO) twice daily (BID) for up to 3 months. Patients also undergo blood sample collection on study. ARM II: Patients receive placebo PO BID for up to 3 months. Patients also undergo blood sample collection on study. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
36
Undergo blood sample collection
Given PO
Given PO
Ancillary studies
City of Hope Medical Center
Duarte, California, United States
RECRUITINGChanges in Brief Pain Inventory-Short Form (BPI-SF) score
The Brief Pain Inventory (BPI) can assess the severity of chronic and acute pain for both behavioral and pharmacological pain interventions. Higher scores from 0 (no pain) to 10 (pain as bad as you can imagine) indicate increased levels of pain. Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: From 0 to 3 months
Changes in Visual Analog Scale (VAS) for Pain
The Visual Analogue Scale (VAS) measures pain intensity with two end points (0=no pain and 10=worst pain). Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: From 0 to 3 months
Changes in Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES) scores
FACT-ES Score measures physical, social and family, emotional, and functional well-being and endocrine symptoms. Higher scores reflect better well-being and fewer symptoms. Score range is 0 to 220. Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: From 0 to 3 months
Incidence of adverse events (AEs)
AEs will be characterized using the descriptions and grading scales of the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Higher grades indicate greater severity.
Time frame: Up to 30 days after last dose of study treatment
Changes in PROMIS Emotional Distress-Anxiety Short Form (SF) 6a Score
The Emotional Distress-Anxiety SF consists of 7 questions regarding feelings of distress/anxiety in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: From 0 to 3 months
Changes in PROMIS Sleep Disturbance Short Form (SF) 4a Score
The Sleep Disturbance SF 4a is an 8-item tool with questions regarding sleep disturbance. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: From 0 to 3 months
Changes in Physical Function by Grip Strength
Grip strength will be quantitated by hand dynamometer (Jarman) at 0 and 3 months. The dominant hand will be recorded for each participant at baseline. This test involves squeezing a dynamometer for 2 to 3 seconds and then releasing. Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: At 0 and up to 3 months
Changes in Alanine Aminotransferase (ALT)
Blood samples will be obtained for testing of alanine transaminase (ALT). An increased ALT indicates a sign of liver dysfunction. Changes will be summarized by treatment arm. Data will be represented using means/medians.
Time frame: At 0, 1, and 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.