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Cannabinoid
Topical Cannabinoids for Musculoskeletal Syndrome
Phase 1
Recruiting
Led By Anne Blaes, MD,MS
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks and 4 weeks
Awards & highlights
Study Summary
This trial will explore if cannabinoid creams can help reduce pain in post-menopausal women with hormone-positive breast cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the cream is applied or allergic reactions if sensitive to cannabinoids. Since it's a topical treatment, systemic side effects are less likely but could still occur depending on individual absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks and 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks and 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
subject recruitment rate
subject retention rate
Secondary outcome measures
change in Brief Pain Inventory Short Form (BPI-SF) scores
tolerability of topical medical cannabis creams
Trial Design
2Treatment groups
Experimental Treatment
Group I: VioletExperimental Treatment1 Intervention
Patients receiving CBD-dominant balm
Group II: Red XsExperimental Treatment1 Intervention
Patients receiving THC-dominant balm
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,945 Total Patients Enrolled
Anne Blaes, MD,MSPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced significant hand or wrist pain or stiffness in the last week.I do not have active skin problems on my hands/wrists that could affect cream absorption.I am 18 years old or older.I have had hand or wrist pain for at least 4 weeks.I am currently receiving or planning to start acupuncture on my arms, wrists, or hands soon.I have been diagnosed with stage I-III breast cancer.I am qualified for the Minnesota Medical Cannabis Program.I started AI therapy within the last 4 years.I am not planning to change my current pain medication doses for AIMSS.I have been on an aromatase inhibitor for at least 60 days and will continue for 4 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Violet
- Group 2: Red Xs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the usage of Red Xs carry any adverse effects on patients?
"Given its Phase 1 status, which entails limited data regarding efficacy and safety, the estimated security of Red Xs is rated a 1 on our scale."
Answered by AI
Are there still opportunities for participants to join this medical experiment?
"Clinicaltrials.gov states that this clinical trial is still recruiting participants after its initial posting date of April 1, 2023 and most recent amendment on June 28th, 2023."
Answered by AI
What is the current scope of participants in this research endeavor?
"Yes, according to the information hosted on clinicaltrials.gov, this investigation is currently enlisting participants - it was initially posted on April 1st 2023 and updated most recently in June 28th of the same year. The research requires 30 individuals from one medical centre."
Answered by AI
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