Topical Cannabinoids for Musculoskeletal Syndrome

Overseen By Anne Blaes, MD,MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must be taking: Aromatase inhibitors

Must not be taking: Cannabinoids

Disqualifiers: Active skin lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 2 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

Who 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

I have experienced significant hand or wrist pain or stiffness in the last week.

Must be willing and able to comply with study visits and procedures

I have had hand or wrist pain for at least 4 weeks.

Exclusion Criteria

Any known or suspected hypersensitivity to topical cannabinoids

I do not have active skin problems on my hands/wrists that could affect cream absorption.

I am currently receiving or planning to start acupuncture on my arms, wrists, or hands soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical cannabinoid creams for AIMSS treatment

2 weeks

Assessments through day 14

Extension

Participants can choose either Red XS or Violet creams for an additional 2-week period

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBD-dominant
• THC dominant

Trial Overview

The CanAroma study tests two topical cannabinoid creams: one THC-dominant and one CBD-dominant, provided by Vireo Health. The goal is to see if these creams are safe, tolerated well, and effective against joint pain caused by breast cancer medication (AIMSS). It's a preliminary step towards larger trials.

How Is the Trial Designed?

Group I: Violet Experimental Treatment 1 Intervention

Patients receiving CBD-dominant balm

Group II: Red Xs Experimental Treatment 1 Intervention

Patients receiving THC-dominant balm

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10061782/

Topical cannabidiol is well tolerated in individuals with a ...

Topical administration of CBD was tolerated well by this population and resulted in only minor adverse effects. As elite athletes are trained ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06320327?term=PRAMOXINE&rank=7

Topical CBD's Effects on Soreness and Performance

Hypothesis 1: CBD cream would decrease perceived muscle soreness when compared to a placebo or control (no cream) group. Aim 2: To assess the effect of topical ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10824304/

Topical Cannabidiol and the Progression Rate of Delayed ...

Both studies found CBD oil to have no significant effect on markers of muscle damage and inflammation (9, 31). Clinical studies have confirmed that CBD reduces ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05170451

NCT05170451 | Topical CBD for Musculoskeletal Pain

Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain. Study Design: The study ...

5.

liebertpub.com

liebertpub.com/doi/10.1089/can.2024.0012

Topical Cannabidiol Application May Not Attenuate Muscle ...

Conclusions: The present pilot study did not discover any significant impacts of CBD cream use for muscle recovery. For individuals seeking to ...

6.

library.samhsa.gov

library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ...

Non-FDA-approved CBD products lack safety standards, may have contaminants, and may contain THC. Limited evidence supports their safety.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10281618/

Cannabidiol for musculoskeletal regenerative medicine - PMC

CBD is considered safe and well tolerated as no serious adverse effects were reported. CBD promotes many positive effects which can manage detrimental ...

8.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1439/cannabidiol

Cannabidiol (Cbd) - Uses, Side Effects, and More

When applied to the skin: A specific cannabis extract spray that contains cannabidiol and THC (Sativex, GW Pharmaceuticals) is possibly safe when used for up to ...