This clinical trial compares the effect of applying a cannabidiol (CBD) dominant cream (Violet) versus a tetrahydrocannabinol (THC) dominant cream (Red XS) in helping patients with pain in their hands due to the use of aromatase inhibitors (AIs) to treat hormone-receptor (HR) positive breast cancer. AIs are commonly used in treating hormone-positive breast cancer. Unfortunately, many patients receiving this treatment experience Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS), with symptoms like joint and bone pain and joint stiffness.
This research study is exploring if topical medical cannabis cream is a treatment option for AIMSS. Specifically, comparing the effectiveness of a cannabis cream that has a higher concentration of THC to a cannabis cream that has a higher concentration of CBD.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05935891.
PRIMARY OBJECTIVE:
I. Demonstrate the feasibility and acceptability to study topical medical cannabis creams from the Minnesota Medical Cannabis Program (MMCP) using randomized trial design by enrolling 30 patients with hormone receptor-positive breast cancer within 12 months from academic (University of Minnesota) and community (HealthPartners/Park Nicollet) cancer clinics.
SECONDARY OBJECTIVES:
I. Generate pilot data on clinical efficacy of topical medical cannabis creams on aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) by documenting the change in Brief Pain Inventory Short Form (BPI-SF) scores (worst pain, average pain, pain interference with general activity) after 2 and 4 weeks of use.
II. Understand tolerability of topical medical cannabis creams by documenting patient adherence to dosing protocol after 2 and 4 week treatment intervals.
III. Explore safety of topical medical cannabis creams by documenting patient descriptions of any perceived adverse events from cream utilization.
CORRELATIVE OBJECTIVES:
I. Measure plasma cannabinoid and estradiol levels at baseline and after 2 and 4 weeks of daily use of topical medical cannabis creams to determine the degree of systemic cannabinoid absorption and impact on estradiol levels.
II. Document patient viewpoints and preferences for using cannabinoid creams beyond 2 week trial period.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply violet balm cannabis cream to the back of each hand for 14 days on trial. Patients then receive their choice of cannabis cream either red XR balm or violet balm for an additional 14 days on trial. Patients undergo collection of blood samples throughout the trial.
ARM II: Patients apply 1 scoop of red XS balm cannabis cream to the back of each hand for 14 days on trial. Patients then receive their choice of cannabis cream either red XR balm or violet balm for an additional 14 days on trial. Patients undergo collection of blood samples throughout the trial.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorAnne Hudson Blaes