Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Phase 2

Completed

Conditions: Breast Cancer
Arthralgia

Interventions: Drug: Cannabidiol (CBD)

Registration Number: NCT04754399

Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 40

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cannabidiol (CBD)	Cannabidiol (CBD)	Oral solution given 2x daily.

Primary Outcome Measures

Name	Time	Method
Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15	Baseline, 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

Name	Time	Method
Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15	Baseline, 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	Baseline, 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	Baseline, week 15	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	End of study (15 weeks)	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	Baseline and week 15	The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.