ArthralgiaPhase 2NCT04754399
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
A Phase 2 study testing Cannabidiol (CBD) in people with Arthralgia and Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Arthralgia, Breast Cancer
- What is being tested?
- Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 10 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
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.
- Conditions
- Arthralgia, Breast Cancer
- Being tested
- Cannabidiol (CBD)
- Keywords
- Cannabidiol
- Medical subject headings
- Arthralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
Also called Epidiolex
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
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Oral solution given 2x daily. Receives: Drug: Cannabidiol (CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline, week 15
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start16 Apr 2021
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Sponsor
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754399
- Sponsor's protocol ID
- UMCC 2020.041
- Other IDs
- HUM00182109
- Status last verified
- May 2025
- First submitted
- 9 Feb 2021
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40751295
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
- ClinicalTrials.gov ID
- NCT04754399
- Acronym / sponsor ID
- UMCC 2020.041
- Conditions
- Arthralgia, Breast Cancer
- Keywords
- Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol (CBD)Oral solution given 2x daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)Also: Epidiolexweek 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 | Drug | Cannabidiol (CBD) |
Primary outcome
Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15
Time frame: 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".
5 secondary outcomes
Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15
Time frame: Baseline, week 15
Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15
Time frame: Baseline, week 15
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Time frame: Baseline, week 15
Number of Treatment Related Adverse Events
Time frame: End of study (15 weeks)
Number of Participants With Undetectable Levels of Estradiol
Time frame: Baseline and week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40751295Fleege 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.
- Individual participant dataSharing planned: No
Related trials for Arthralgia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Estrogen Receptor-Positive Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norah L Henry, MD, PhD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol (CBD) in people with Arthralgia and Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15 (time frame: Baseline, week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.