Health Trials

High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer

ConditionsAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Breast AdenocarcinomaBreast Ductal Carcinoma In SituEstrogen Receptor-Positive Breast CarcinomaProgesterone Receptor-Positive Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a "high" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.

Eligibility criteria

Qualifiers

Documented informed consent of the participant

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Postmenopausal by last menses > 12 months or medically induced menopause in premenopausal women for AI therapy use

Disqualifiers

< 3 months since prior cannabinoid containing cannabis or hemp products including CBD, tetrahydrocannabinol (THC), Marinol, and Epidiolex and must agree to refrain from use from sources outside of this study

< 28 days since prior investigational agents

Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days

Narcotic use within 14 days of registration

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • BRC-001
  • Placebo Administration
  • Questionnaire Administration

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

1
City of Hope Medical Center91010, DuarteCalifornia, United States

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Biopharmaceutical Research Company

Collaborator

Source ClinicalTrials.gov