Musculoskeletal SyndromeEarly Phase 1NCT05935891
A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)
A Early Phase 1 study testing CBD-dominant and THC dominant in people with Musculoskeletal Syndrome, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Syndrome
- What is being tested?
- CBD-dominant and THC dominant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 29 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above at the time of signing the informed consent form.
- Histologically proven diagnosis of stage I-III invasive breast cancer.
- Currently taking prescribed dose of an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane) for at least 60 days with a plan to continue for at least 4 weeks after time of consent.
- Initiated AI therapy must have been within 48 months at time of consent.
- Experiencing AIMSS in hands and/or wrists for at least 4 weeks prior to time of consent.
- Patients must have reported a score of 4 or higher on at least one of the four M-SACRAH questions regarding pain and stiffness in hands and/or wrists over the past 7 days. Patients experiencing AIMSS symptoms in other joints are eligible, but must have pain in hands and/or wrists.
Show all 12Show fewer
- Must be willing and able to comply with study visits and procedures.
- Must be willing to be registered in the Minnesota Medical Cannabis Program (MMCP).
- Must meet qualifications for the Minnesota Medical Cannabis
- Program (MMCP). This includes:
- Must have a qualifying condition, as per MMCP requirements, that is certified by a Health Care Practitioner.
- Must be a Minnesota resident.
Who cannot join
- The patient is currently using or has used cannabinoids within 4 weeks of time of consent.
- Active skin lesions on hands/wrists that the investigator feels could impair absorption of cannabinoid cream or lead to increased toxicity (e.g., psoriasis, cellulitis, cutaneous lupus erythematosus, hand-foot syndrome).
- Plan to start or increase doses of other analgesics aimed at improving AIMSS symptoms (e.g., duloxetine, non-steroidal anti- inflammatories, acetaminophen, opioids). Of note, patients are eligible if they have remained on stable doses of AIMSS related medications for 4 weeks prior to time of consent and do not plan to escalate the dose.
- Current or planned initiation of acupuncture to arms, wrists or hands within study period.
- Any known or suspected hypersensitivity to topical cannabinoids.
- Any condition that the investigator believes would interfere with the ability to provide informed consent, comply with the study protocol, or would put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- CBD-dominant, THC dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD-dominantDrug
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.
THC dominantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Violet | Experimental | Patients receiving CBD-dominant balm Receives: Drug: CBD-dominant |
| Red Xs | Experimental | Patients receiving THC-dominant balm Receives: Drug: THC dominant |
What is being measured
The primary outcome is the main question the study is designed to answer.
subject recruitment rate
percentage of participants actually recruited out of anticipated
Measured: 4 weeks
subject retention rate
percentage of participants who completed the study
Measured: 4 weeks
Secondary outcomes (2)
change in Brief Pain Inventory Short Form (BPI-SF) scores
worst pain, average pain, pain interference with general activity minimum value is zero equals no pain and maximum value is 10 equals pain as bad as you can imagine and the higher the score the worse the outcome.
Measured: 2 weeks and 4 weeks
tolerability of topical medical cannabis creams
documenting patient adherence to dosing protocol through a Patient Topical Cannabis Dosing Diary.
This is a document where the patient records the date, time, to which hands the dose was applied and if the dose was missed.
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start9 Feb 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized to CBD-dominant (Violet) and THC-dominant (Red XS) balms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Blaes, MD,MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935891
- Sponsor's protocol ID
- AIMSS
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zylla D, Idossa D, Borrero M, Napurski C, Dahmer S, Cowger J, Gilmore G, Luo X, Birnbaum A, Blaes AH. A Randomized, Open-Label Trial to Assess Feasibility and Tolerability of Topical Cannabis Balms for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS). Cannabis Cannabinoid Res. 2026 Feb;11(1):30-35. doi: 10.1177/25785125251398286. Epub 2025 Dec 29.
PubMed 41467893
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)
- ClinicalTrials.gov ID
- NCT05935891
- Acronym / sponsor ID
- AIMSS
- Conditions
- Musculoskeletal Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized to CBD-dominant (Violet) and THC-dominant (Red XS) balms.
| Arm | Type | Receives |
|---|---|---|
| Violet | Experimental | Drug: CBD-dominantPatients receiving CBD-dominant balm |
| Red Xs | Experimental | Drug: THC dominantPatients receiving THC-dominant balm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or above at the time of signing the informed consent form.
- Histologically proven diagnosis of stage I-III invasive breast cancer.
- Currently taking prescribed dose of an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane) for at least 60 days with a plan to continue for at least 4 weeks after time of consent.
- Initiated AI therapy must have been within 48 months at time of consent.
- Experiencing AIMSS in hands and/or wrists for at least 4 weeks prior to time of consent.
Key exclusion criteria (6 listed)
- The patient is currently using or has used cannabinoids within 4 weeks of time of consent.
- Active skin lesions on hands/wrists that the investigator feels could impair absorption of cannabinoid cream or lead to increased toxicity (e.g., psoriasis, cellulitis, cutaneous lupus erythematosus, hand-foot syndrome).
- Plan to start or increase doses of other analgesics aimed at improving AIMSS symptoms (e.g., duloxetine, non-steroidal anti- inflammatories, acetaminophen, opioids). Of note, patients are eligible if they have remained on stable doses of AIMSS related medications for 4 weeks prior to time of consent and do not plan to escalate the dose.
- Current or planned initiation of acupuncture to arms, wrists or hands within study period.
- Any known or suspected hypersensitivity to topical cannabinoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD-dominantproduct 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 | Violet |
| THC dominantcontains 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. | Drug | Red Xs |
Primary outcome
subject recruitment rate
Time frame: 4 weeks
percentage of participants actually recruited out of anticipated
subject retention rate
Time frame: 4 weeks
percentage of participants who completed the study
2 secondary outcomes
change in Brief Pain Inventory Short Form (BPI-SF) scores
Time frame: 2 weeks and 4 weeks
tolerability of topical medical cannabis creams
Time frame: 2 weeks and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 41467893Zylla D, Idossa D, Borrero M, Napurski C, Dahmer S, Cowger J, Gilmore G, Luo X, Birnbaum A, Blaes AH. A Randomized, Open-Label Trial to Assess Feasibility and Tolerability of Topical Cannabis Balms for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS). Cannabis Cannabinoid Res. 2026 Feb;11(1):30-35. doi: 10.1177/25785125251398286. Epub 2025 Dec 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Blaes, MD,MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CBD-dominant and THC dominant in people with Musculoskeletal Syndrome, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subject recruitment rate (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.