NCT05935891

A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aromatase inhibitors (AIs) are commonly used for post-menopausal women with hormone-positive breast cancer. Compared to tamoxifen, AIs improve breast cancer recurrence rates and lower 10-year breast cancer mortality. Unfortunately, nearly 2 out of 3 women with estrogen-receptor positive breast cancer treated with AIs experiences AIMSS, such as arthralgia, joint stiffness, and bone pain, and 30% of women with AIMSS report severe pain. AIMSS leads to poor adherence with therapy and discontinuation of therapy in up to 20% of patients. Despite the large number of women affected, current therapeutic interventions have shown only limited efficacy in improving AIMSS. Therefore, the presence of AIMSS may negatively impact breast cancer recurrence and survival. In this current trial, the plan is to utilize topical cannabinoid creams from Vireo Health that have been tested for potency and purity. Two distinct products with different THC/CBD ratios will be provided to patients at no cost; a) a THC-dominant cream (Red XS Balm with 375mg/jar and \<20mg of CBD) and b) a CBD-dominant cream (Violet Balm with 2210mg CBD/jar and \<0.3% THC). The study will explore the feasibility of doing larger, placebo controlled trials by first ensuring adequate patient interest, acceptable tolerability/safety of cream utilization, and preliminary efficacy measures. All patients completing assessments through day 14 will be allowed to choose either Red XS or Violet creams for an additional 2-week extension period.

Conditions

• Musculoskeletal Syndrome

Interventions

Type	Name	Description
DRUG	CBD-dominant	product contains 2210 mg CBD and less than 0.3% THC per 1.5 ounce jar. Patients will be provided a 2-week supply of creams (3 jars for each 14 day interval) by Vireo Health, according to the randomization arm. Patient will be instructed to apply the topical products using the 1.25cc spoon provided (there are approximately 35 scoops per 1.5oz jar). The patient will apply one scoop of cream to the back of each hand and then rub into the entire hand, wrist, and all fingers. After the 14 day assessment, patients will be transitioned to a two-week open label extension that allows them to choose their preference of either Red XS or Violet cream at no cost.
DRUG	THC dominant	contains 375mg THC and less than 20mg CBD per 1.5 ounce jar. Patients will be provided a 2-week supply of creams (3 jars for each 14 day interval) by Vireo Health, according to the randomization arm. Patient will be instructed to apply the topical products using the 1.25cc spoon provided (there are approximately 35 scoops per 1.5oz jar). The patient will apply one scoop of cream to the back of each hand and then rub into the entire hand, wrist, and all fingers. After the 14 day assessment, patients will be transitioned to a two-week open label extension that allows them to choose their preference of either Red XS or Violet cream at no cost.

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2023-07-07
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study