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

NCT04754399 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: UMCC 2020.041HUM00182109
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthralgia; Breast Cancer

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15

  Baseline, week 15

• Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15

  Baseline, week 15

• Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1

  Baseline, week 15

• Number of Treatment Related Adverse Events

  End of study (15 weeks)

• Number of Participants With Undetectable Levels of Estradiol

  Baseline and week 15

Study Arms (1)

Cannabidiol (CBD)

EXPERIMENTAL

Oral solution given 2x daily.

Drug: Cannabidiol (CBD)

Interventions

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

Also known as: Epidiolex

Cannabidiol (CBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 40751295 DERIVED

MeSH Terms

Conditions

Arthralgia; Breast Neoplasms

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: April 16, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)