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NCT06538389 · ClinicalTrials.gov registry record · Phase 2
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
A Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06538389: Recruiting Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT06538389 is a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 36 participants, below the 356-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06538389, a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG BRC-001
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-08-26 |
| Est. Completion | 2026-08-15 |
| Phase | Phase 2 |
What NCT06538389 shows while recruiting
NCT06538389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 356-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (90% lower).
The record links to 8 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT06538389 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06538389 about?
NCT06538389 is a clinical study titled "High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer". 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. Wo...
What is the current status of trial NCT06538389?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-08-26. Estimated completion is 2026-08-15.
What conditions does trial NCT06538389 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Breast Adenocarcinoma, Breast Ductal Carcinoma In Situ.
What interventions are being tested in trial NCT06538389?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Placebo Administration (DRUG), BRC-001 (DRUG).
Who is sponsoring clinical trial NCT06538389?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06538389 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06538389's enrollment target sits among peer trials
36 56th of 73 higher than 18 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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