RecruitingPhase 2NCT06538389

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

High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial

Sponsor

City of Hope Medical Center

Enrollment

36 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Breast Adenocarcinoma Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a high-CBD plant extract (BRC-001) for women with breast cancer who experience joint pain caused by aromatase inhibitors — hormone-blocking medications commonly prescribed after breast cancer treatment. Joint pain is a major reason women stop taking these life-saving drugs. **You may be eligible if...** - You are 18 or older with confirmed breast cancer (Stage 0–IIIA, no metastasis) - You have undergone definitive surgery and are taking aromatase inhibitor therapy - You are postmenopausal (naturally or medically induced) - You read English or Spanish **You may NOT be eligible if...** - You have metastatic breast cancer - You have had another cancer within the last 5 years (with limited exceptions for fully treated early cancers) - You do not meet the hormonal or treatment status requirements for aromatase inhibitor therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGBRC-001

Given PO

DRUGPlacebo Administration

Given PO

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06538389

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