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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Violet | Experimental | Patients receiving CBD-dominant balm |
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| Red Xs | Experimental | Patients receiving THC-dominant balm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD-dominant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| subject recruitment rate | percentage of participants actually recruited out of anticipated | 4 weeks |
| subject retention rate | percentage of participants who completed the study | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks and 4 weeks |
| tolerability of topical medical cannabis creams |
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Inclusion Criteria:
Program (MMCP). This includes:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Blaes, MD,MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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Eligible patients will be randomized to CBD-dominant (Violet) and THC-dominant (Red XS) balms.
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Patients will be informed as to which product they are using.
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| THC dominant | Drug | 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. |
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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. |
| 2 weeks and 4 weeks |