Back to resultsCannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Primary Purpose
Arthralgia, Breast Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol (CBD)
Sponsored by
About this trial
This is an interventional supportive care trial for Arthralgia focused on measuring Cannabidiol
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal according to standard clinical criteria OR receiving concomitant LHRH agonist therapy.
- Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
- Planning to take the same AI therapy for at least 15 weeks.
- New or worsening joint pain and/or myalgias since starting the AI therapy.
- Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment.
- The complete list of inclusion criteria is provided in the protocol.
Exclusion Criteria:
- Metastatic breast cancer.
- Planned surgery during the 15-week study period.
- Clinically significant laboratory abnormalities.
- Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment.
- History of or currently has suicidal ideation or attempted suicide.
- History of seizure other than febrile seizures in childhood.
- The complete list of exclusion criteria is provided in the protocol.
Sites / Locations
- University of Michigan Rogel Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cannabidiol (CBD)
Arm Description
Oral solution given 2x daily.
Outcomes
Primary Outcome Measures
Absolute change in Brief Pain Inventory (BPI) worst pain from baseline to week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
Secondary Outcome Measures
Number of patients with at least a 2-point reduction in BPI worst pain from baseline to week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.
Number of patients with at least a 2-point reduction in BPI average pain from baseline to week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.
Change in symptoms from baseline, as measured by the PROMIS-29+2 Profile v2.1
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.
Number of treatment related adverse events
Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.
Number of participants with undetectable levels of estradiol
The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.
Full Information
NCT ID
NCT04754399
First Posted
February 9, 2021
Last Updated
July 17, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
American Society of Clinical Oncology
1. Study Identification
Unique Protocol Identification Number
NCT04754399
Brief Title
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Official Title
Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
American Society of Clinical Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, Breast Cancer
Keywords
Cannabidiol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cannabidiol (CBD)
Arm Type
Experimental
Arm Description
Oral solution given 2x daily.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol (CBD)
Other Intervention Name(s)
Epidiolex
Intervention Description
week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
Primary Outcome Measure Information:
Title
Absolute change in Brief Pain Inventory (BPI) worst pain from baseline to week 15
Description
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
Time Frame
Baseline, week 15
Secondary Outcome Measure Information:
Title
Number of patients with at least a 2-point reduction in BPI worst pain from baseline to week 15
Description
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.
Time Frame
Baseline, week 15
Title
Number of patients with at least a 2-point reduction in BPI average pain from baseline to week 15
Description
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.
Time Frame
Baseline, week 15
Title
Change in symptoms from baseline, as measured by the PROMIS-29+2 Profile v2.1
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.
Time Frame
Baseline, week 15
Title
Number of treatment related adverse events
Description
Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.
Time Frame
End of study (15 weeks)
Title
Number of participants with undetectable levels of estradiol
Description
The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.
Time Frame
Baseline and week 15
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal according to standard clinical criteria OR receiving concomitant LHRH agonist therapy.
Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
Planning to take the same AI therapy for at least 15 weeks.
New or worsening joint pain and/or myalgias since starting the AI therapy.
Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment.
The complete list of inclusion criteria is provided in the protocol.
Exclusion Criteria:
Metastatic breast cancer.
Planned surgery during the 15-week study period.
Clinically significant laboratory abnormalities.
Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment.
History of or currently has suicidal ideation or attempted suicide.
History of seizure other than febrile seizures in childhood.
The complete list of exclusion criteria is provided in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norah L Henry, MD, PhD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
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