Back to resultsA Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)
Primary Purpose
Musculoskeletal Syndrome
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBD-dominant
THC dominant
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Syndrome
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Violet
Red Xs
Arm Description
Patients receiving CBD-dominant balm
Patients receiving THC-dominant balm
Outcomes
Primary Outcome Measures
subject recruitment rate
percentage of participants actually recruited out of anticipated
subject retention rate
percentage of participants who completed the study
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05935891
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomized to CBD-dominant (Violet) and THC-dominant (Red XS) balms.
Masking
None (Open Label)
Masking Description
Patients will be informed as to which product they are using.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Violet
Arm Type
Experimental
Arm Description
Patients receiving CBD-dominant balm
Arm Title
Red Xs
Arm Type
Experimental
Arm Description
Patients receiving THC-dominant balm
Intervention Type
Drug
Intervention Name(s)
CBD-dominant
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
THC dominant
Intervention Description
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.
Primary Outcome Measure Information:
Title
subject recruitment rate
Description
percentage of participants actually recruited out of anticipated
Time Frame
4 weeks
Title
subject retention rate
Description
percentage of participants who completed the study
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
change in Brief Pain Inventory Short Form (BPI-SF) scores
Description
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.
Time Frame
2 weeks and 4 weeks
Title
tolerability of topical medical cannabis creams
Description
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.
Time Frame
2 weeks and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Blaes, MD,MS
Phone
612-625-9604
Email
blaes004@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Blaes, MD,MS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Napurski, MPH, CCRP
Phone
612-626-2140
Email
bake0257@umn.edu
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)
We'll reach out to this number within 24 hrs