High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
NCT Number: NCT06538389
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: 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
Interventions: PROCEDURE: Biospecimen Collection|DRUG: BRC-001|DRUG: Placebo Administration|OTHER: Questionnaire Administration
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)|Biopharmaceutical Research Company
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-08-15
Completion Date: 2026-08-15
Locations: City of Hope Medical Center, Duarte, California, 91010, United States

Summary:
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.

Primary Outcome Measures: Changes in Brief Pain Inventory-Short Form (BPI-SF) score, The Brief Pain Inventory (BPI) can assess the severity of chronic and acute pain for both behavioral and pharmacological pain interventions. Higher scores from 0 (no pain) to 10 (pain as bad as you can imagine) indicate increased levels of pain. Changes will be summarized by treatment arm. Data will be represented using means/medians., From 0 to 3 months
Secondary Outcome Measures: Changes in Visual Analog Scale (VAS) for Pain, The Visual Analogue Scale (VAS) measures pain intensity with two end points (0=no pain and 10=worst pain). Changes will be summarized by treatment arm. Data will be represented using means/medians., From 0 to 3 months|Changes in Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES) scores, FACT-ES Score measures physical, social and family, emotional, and functional well-being and endocrine symptoms. Higher scores reflect better well-being and fewer symptoms. Score range is 0 to 220. Changes will be summarized by treatment arm. Data will be represented using means/medians., From 0 to 3 months|Incidence of adverse events (AEs), AEs will be characterized using the descriptions and grading scales of the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Higher grades indicate greater severity., Up to 30 days after last dose of study treatment|Changes in PROMIS Emotional Distress-Anxiety Short Form (SF) 6a Score, The Emotional Distress-Anxiety SF consists of 7 questions regarding feelings of distress/anxiety in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. Changes will be summarized by treatment arm. Data will be represented using means/medians., From 0 to 3 months|Changes in PROMIS Sleep Disturbance Short Form (SF) 4a Score, The Sleep Disturbance SF 4a is an 8-item tool with questions regarding sleep disturbance. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. Changes will be summarized by treatment arm. Data will be represented using means/medians., From 0 to 3 months|Changes in Physical Function by Grip Strength, Grip strength will be quantitated by hand dynamometer (Jarman) at 0 and 3 months. The dominant hand will be recorded for each participant at baseline. This test involves squeezing a dynamometer for 2 to 3 seconds and then releasing. Changes will be summarized by treatment arm. Data will be represented using means/medians., At 0 and up to 3 months|Changes in Alanine Aminotransferase (ALT), Blood samples will be obtained for testing of alanine transaminase (ALT). An increased ALT indicates a sign of liver dysfunction. Changes will be summarized by treatment arm. Data will be represented using means/medians., At 0, 1, and 3 months