High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
Suspended
Phase 2
Interventional Study
Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Breast Adenocarcinoma
Breast Ductal Carcinoma In Situ
Estrogen Receptor-Positive Breast Carcinoma
Progesterone Receptor-Positive Breast Carcinoma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 36 (estimated)
- Sponsor
- City of Hope Medical Center · Other
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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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* At least 5 years since other malignancy exce…
Contacts
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