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.
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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…
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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…
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