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Cannabinoid
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Phase 2
Waitlist Available
Led By Norah L Henry, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
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 baseline, week 15
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial is testing if CBD can help reduce joint pain in postmenopausal women who have pain from taking breast cancer medications. CBD works by interacting with the body's system that controls pain and inflammation. CBD has been studied for its potential to block pain and prevent nerve damage in conditions like osteoarthritis, and it is considered safe for trial in various chronic pain conditions.
Eligible Conditions
- Severe Joint Pain
- Breast Cancer
- Joint Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 15
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute change in Brief Pain Inventory (BPI) worst pain from baseline to week 15
Secondary study objectives
Change in symptoms from baseline, as measured by the PROMIS-29+2 Profile v2.1
Number of participants with undetectable levels of estradiol
Number of patients with at least a 2-point reduction in BPI average pain from baseline to week 15
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cannabidiol (CBD)Experimental Treatment1 Intervention
Oral solution given 2x daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,175 Total Patients Enrolled
American Society of Clinical OncologyOTHER
37 Previous Clinical Trials
148,099 Total Patients Enrolled
Norah L Henry, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
10 Previous Clinical Trials
529 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol (CBD)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.