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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00182109 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| American Society of Clinical Oncology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol (CBD) | Experimental | Oral solution given 2x daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol (CBD) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Baseline, week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norah L Henry, MD, PhD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40751295 | Derived | Fleege NMG, Miller EA, Kidwell KM, Zacharias ZR, Houtman J, Scheu K, Kemmer K, Boehnke KF, Henry NL. Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer. Cancer Med. 2025 Aug;14(15):e71117. doi: 10.1002/cam4.71117. |
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1 subject was enrolled but deemed ineligible before starting treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | 11 patients missing data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, week 15 |
|
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cannabidiol (CBD)- Week 1 | Oral solution given 2x daily. Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2022 | Oct 30, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2022 | Sep 24, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
|
| Baseline, week 15 |
| 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. | Baseline, week 15 |
| 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. | Baseline, week 15 |
| 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. | End of study (15 weeks) |
| 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. | Baseline and week 15 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | 11 patients missing data | Posted | Count of Participants | Participants | Baseline, week 15 |
|
|
|
| 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. | 11 patients missing data | Posted | Count of Participants | Participants | Baseline, week 15 |
|
|
|
| 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. | 11 patients missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 15 |
|
|
|
| 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. | Posted | Number | number of events | End of study (15 weeks) |
|
|
|
| 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. | All enrolled patients would be analyzed; however, 3 samples are missing for baseline and 9 for week 15 | Posted | Count of Participants | Participants | Baseline and week 15 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 12 |
| 39 |
| EG001 | CBD- Week 2 | Oral solution given 2x daily. Cannabidiol (CBD): week 2: 50 mg twice daily, approximately 12 hours apart, with food | 0 | 39 | 0 | 39 | 3 | 39 |
| EG002 | CBD- Week 3 | Oral solution given 2x daily. Cannabidiol (CBD): week 3: 75 mg twice daily, approximately 12 hours apart, with food | 0 | 39 | 0 | 39 | 8 | 39 |
| EG003 | CBD- Week 4 | Oral solution given 2x daily. Cannabidiol (CBD): week 4+: 100 mg twice daily, approximately 12 hours apart, with food | 0 | 39 | 0 | 39 | 11 | 39 |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Depression |
|
| Ability to participate in social roles/activities |
|
| Anxiety |
|
| Physical function |
|
| Fatigue |
|
| Sleep disturbance |
|
| Title | Measurements |
|---|---|
|
| Anxiety- grade 1- 50mg BID dose |
|
| Rash- grade 2- 50mg BID dose |
|
| Nausea- grade 1- 50mg BID dose |
|
| Depression- grade 1- 75 mg BID dose |
|
| Stomach Pain- grade 1- 75 mg BID dose |
|
| Fatigue- grade 1- 75 mg BID dose |
|
| Headache- grade 1- 75 mg BID dose |
|
| Hyponatremia- grade 1- 75 mg BID dose |
|
| Hyperglycemia- grade 1- 75 mg BID dose |
|
| Peripheral motor neuropathy- grade 1- 100 mg BID dose |
|
| Peripheral motor neuropathy- grade 2- 100 mg BID dose |
|
| Fatigue- grade 1- 100 mg BID dose |
|
| Memory impairment- grade 1- 100 mg BID dose |
|
| Anorexia- grade 2- 100 mg BID dose |
|
| Diarrhea- grade 2- 100 mg BID dose |
|
| Nausea- grade 1 - 100 mg BID dose |
|
| alanine aminotransferase increased- grade 1- 100 mg BID dose |
|
| Oral Pain- grade 1- 100 mg BID dose |
|
| Gastroesophageal reflux disease- grade1- 100 mg BID dose |
|
| Increased creatinine- grade 1- 100 mg BID dose |
|
| stomach pain- grade 1- 100 mg BID dose |
|
| dizziness- grade 1- 100 mg BID dose |
|
| Headache- grade 1- 100 mg BID dose |
|
|