Arthralgia, Breast Cancer
Conditions
Keywords
Cannabidiol
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.
Interventions
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
Sponsors
American Society of Clinical Oncology
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
1 subject was enrolled but deemed ineligible before starting treatment
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol (CBD) Oral solution given 2x daily.
Cannabidiol (CBD): 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 | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Cannabidiol (CBD) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 12 / 39 | 3 / 39 | 8 / 39 | 11 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 | 0 / 39 |
Outcome results
Primary
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.
Time frame: Baseline, week 15
Population: 11 patients missing data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cannabidiol (CBD) | Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15 | -2.4 units on a scale |
Secondary
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.
Time frame: Baseline, week 15
Population: 11 patients missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Pain interference | -6.5 score on a scale | Standard Deviation 7.2 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Pain intensity | -1.9 score on a scale | Standard Deviation 2.1 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Cognitive function | 2.0 score on a scale | Standard Deviation 1.2 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Depression | -1.7 score on a scale | Standard Deviation 4.5 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Ability to participate in social roles/activities | 5.7 score on a scale | Standard Deviation 8 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Anxiety | -3.4 score on a scale | Standard Deviation 6 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Physical function | 3.9 score on a scale | Standard Deviation 5.3 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Sleep disturbance | -3.7 score on a scale | Standard Deviation 6.6 |
| Cannabidiol (CBD) | Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 | Fatigue | -3.3 score on a scale | Standard Deviation 6.9 |
Secondary
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.
Time frame: Baseline and week 15
Population: All enrolled patients would be analyzed; however, 3 samples are missing for baseline and 9 for week 15
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cannabidiol (CBD) | Number of Participants With Undetectable Levels of Estradiol | Baseline | 8 Participants |
| Cannabidiol (CBD) | Number of Participants With Undetectable Levels of Estradiol | 15 Weeks | 4 Participants |
Secondary
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.
Time frame: Baseline, week 15
Population: 11 patients missing data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cannabidiol (CBD) | Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15 | 14 Participants |
Secondary
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.
Time frame: Baseline, week 15
Population: 11 patients missing data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cannabidiol (CBD) | Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15 | 17 Participants |
Secondary
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.
Time frame: End of study (15 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Agitation- grade 2- 25mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Nausea- grade 1- 25mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Flushing- grade 1- 25mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Anxiety- grade 1- 50mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Rash- grade 2- 50mg BID dose | 2 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Nausea- grade 1- 50mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Depression- grade 1- 75 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Stomach Pain- grade 1- 75 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Fatigue- grade 1- 75 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Headache- grade 1- 75 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Hyponatremia- grade 1- 75 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Hyperglycemia- grade 1- 75 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Peripheral motor neuropathy- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Fatigue- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Memory impairment- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Anorexia- grade 2- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Diarrhea- grade 2- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Nausea- grade 1 - 100 mg BID dose | 2 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | alanine aminotransferase increased- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Oral Pain- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Gastroesophageal reflux disease- grade1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Peripheral motor neuropathy- grade 2- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Increased creatinine- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | stomach pain- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | dizziness- grade 1- 100 mg BID dose | 1 number of events |
| Cannabidiol (CBD) | Number of Treatment Related Adverse Events | Headache- grade 1- 100 mg BID dose | 1 number of events |