Topical Cannabinoids for Musculoskeletal Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two types of topical cannabinoid creams to determine their effectiveness in relieving pain and stiffness in the hands and wrists caused by aromatase inhibitors, a common breast cancer treatment. One cream contains high levels of THC (tetrahydrocannabinol), while the other is rich in CBD (cannabidiol). The goal is to assess whether these creams are safe, well-tolerated, and potentially effective for symptom management. The trial seeks participants who have had breast cancer and currently experience joint pain or stiffness from their treatment. Participants must reside in Minnesota and be part of the Minnesota Medical Cannabis Program. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to explore new pain relief options.
Do I have to stop taking my current medications for the trial?
You don't have to stop your current medications, but you must have been on a stable dose for at least 4 weeks before joining the trial and not plan to increase the dose. If you're using cannabinoids, you need to stop them at least 4 weeks before joining.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that CBD creams applied to the skin are generally safe and well-tolerated. Past studies found no serious side effects, and even top athletes used them for pain relief without issues. However, exercise caution with CBD products not approved by the FDA, as they might contain impurities.
For creams with more THC, studies indicate that applying them to the skin is unlikely to cause a "high" because only a small amount of THC enters the bloodstream. This suggests they are safe, though tiny amounts might still appear in the body.
In summary, both CBD and THC creams appear safe according to current research. However, these results might not be the same for everyone.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using topical cannabinoids for musculoskeletal syndrome because these treatments offer a new approach compared to standard options like NSAIDs or physical therapy. The CBD-dominant balm works by leveraging the anti-inflammatory properties of CBD, potentially reducing pain without the psychoactive effects associated with THC. Meanwhile, the THC-dominant balm may provide enhanced pain relief through its interaction with the body's endocannabinoid system, which is different from traditional painkillers. These unique mechanisms could offer patients faster and potentially safer relief from musculoskeletal pain.
What evidence suggests that this trial's treatments could be effective for AIMSS?
Research has shown that creams with CBD, which participants in this trial may receive as part of the Violet arm, might help with muscle and joint pain. Some studies suggest that CBD creams can ease pain more effectively than a placebo. However, results vary, and some research finds no major effect on muscle recovery.
Meanwhile, studies have found that creams with more THC, which participants in this trial may receive as part of the Red Xs arm, can significantly reduce chronic pain. Some people report over 50% less pain compared to a placebo. This suggests that THC creams might help with joint pain and stiffness. While not everyone experiences the same results, many find these treatments useful for easing discomfort.14678Who Is on the Research Team?
Anne Blaes, MD,MS
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults in Minnesota with hormone receptor-positive breast cancer who have been on aromatase inhibitors for at least 60 days and are experiencing joint pain from the treatment. Participants must be willing to join the Minnesota Medical Cannabis Program, not use other cannabinoids recently, and not plan to start new pain medications or therapies like acupuncture during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topical cannabinoid creams for AIMSS treatment
Extension
Participants can choose either Red XS or Violet creams for an additional 2-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CBD-dominant
- THC dominant
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor