Trial Title:
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
NCT ID:
NCT06538389
Condition:
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
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Carcinoma, Ductal, Breast
Arthralgia
Cannabidiol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (BRC-001)
Arm group label:
Arm II (Placebo)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
BRC-001
Description:
Given PO
Arm group label:
Arm I (BRC-001)
Other name:
Cannabidiol
Other name:
CBD
Other name:
CBD Oil
Intervention type:
Drug
Intervention name:
Placebo Administration
Description:
Given PO
Arm group label:
Arm II (Placebo)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (BRC-001)
Arm group label:
Arm II (Placebo)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the preliminary efficacy of BRC-001 versus placebo by change in Brief Pain
Inventory-Short Form (BPI-SF) worst pain severity scores from 0 to 3 months.
SECONDARY OBJECTIVES:
I. To evaluate indicators of preliminary efficacy of BRC-001 on joint symptoms of pain
and stiffness assessed by BPI-SF total pain severity and total pain interference scores
and Visual Analog Scale-Pain.
II. To evaluate tolerability by adverse events, anxiety by Patient Reported Outcomes
Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form (SF) 6a,
sleep by PROMIS Sleep Disturbance SF 4a, quality of life by Functional Assessment of
Cancer Therapy-Endocrine System (FACT-ES).
III. To evaluate safety by clinical laboratory tests (alanine aminotransferase [ALT],
aspartate aminotransferase [AST], total bilirubin).
IV. To evaluate changes in physical function by dynamometer measurements of grip
strength.
EXPLORATORY OBJECTIVES:
I. To evaluate blood-based biomarkers related to aromatase inhibitor-induced arthralgia
(AIIA) and BRC-001 versus (vs) placebo.
II. Pharmacokinetics of BRC-001.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive BRC-001 orally (PO) twice daily (BID) for up to 3 months.
Patients also undergo blood sample collection on study.
ARM II: Patients receive placebo PO BID for up to 3 months. Patients also undergo blood
sample collection on study.
After completion of study treatment, patients are followed up at 30 days.
Criteria for 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 except adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or
II cancer from which the patient is currently in complete remission
- Ability to read and understand English, Spanish, or translations by interpreters for
questionnaires
- Histologically confirmed primary invasive adenocarcinoma of the breast or ductal
carcinoma in situ of the breast
- Stage 0, I, II, or IIIA disease
- No metastatic disease
- Must have undergone definitive breast cancer surgery and recovered
- Must have completed adjuvant chemotherapy as applicable, including systemic
chemotherapy, anti-HER2 therapy, and/or radiation therapy
- Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)
- Currently taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole
[Arimidex (registered trademark)], letrozole [Femara (registered trademark)], or
exemestane [Aromasin (registered trademark)]) for ≥ 90 days prior to registration
with plans to continue for ≥ 180 days after registration
- Must have a worst pain/stiffness of ≥ 4 on the Brief Pain Inventory (BPI) (item #2)
that has started or increased with AI therapy
Exclusion Criteria:
- < 3 months since prior cannabinoid containing cannabis or hemp products including
CBD, tetrahydrocannabinol (THC), Marinol, and Epidiolex and must agree to refrain
from use from sources outside of this study
- < 28 days since prior investigational agents
- Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness
within the past 30 days
- Narcotic use within 14 days of registration
- Patients may have received corticosteroid treatment; however, the following criteria
apply:
- Patients must not have received oral or intramuscular corticosteroids within 28
days prior to registration
- Patients must not have received intra-articular steroids to the study, or any
other, joint within 28 days prior to registration
- Patients must not have received topical analgesics (e.g., capsaicin preparations) to
the study joint or any other analgesics (e.g., opiates, tramadol; with exception of
nonsteroidal anti-inflammatory drugs [NSAIDs] and acetaminophen) within 14 days
prior to registration
- History of bone fracture or surgery of the afflicted hands, knees, and/or other
joints within 6 months prior to registration
- Any uncontrolled illness including ongoing or active infection
- Known allergies or contraindications to cannabis
- Significantly impaired hepatic function (alanine aminotransferase [ALT] > 5 x upper
limit of normal [ULN] or total bilirubin [TBL] > 2 x ULN) OR the ALT or aspartate
aminotransferase (AST) > 3 x ULN and TBL > 2 x ULN (or international normalized
ratio [INR] > 1.5
- Grade 3+ renal impairment
- Clinically significant lab abnormalities in ALT, AST, total bilirubin, hemoglobin,
hematocrit, or creatinine or any other laboratory tests that in the opinion of the
investigator would prevent the patient from safely participating in the study
- Having current thoughts of suicide or self-harm or history of suicidal ideation or
attempted suicide
- Meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)
criteria for current major psychiatric illness, such as bipolar disorder, major
depression, or psychosis (including schizophrenia and affective psychosis)
- History of seizure disorder
- Concomitant administration with drugs that may interact adversely with CBD including
warfarin, theophylline, amiodarone, anti-epileptic (e.g., clobazam, stiripentol,
valproate, topiramate), anticonvulsant (e.g., diazepam, lamotrigine, phenytoin,
ethosuximide, oxcarbazepine, pregabalin, tigabine, gabapentin); 3) barbiturate
(e.g., phenobarbital, hexobarbital), benzodiazepine (e.g, chlordiazepoxide,
clonazepam), opioid/narcotic (e.g, codeine, morphine)
- Concomitant administration of cyclin-dependent kinase 4/6 inhibitors, such as
abemaciclib, with AI therapy
- Following a physical examination, the patient has any abnormalities that, in the
opinion of the investigator would prevent the patient from safely participating in
the study
- Other active malignancy
- Any other condition or medication use that would, in the Investigator's judgment,
contraindicate the patient's participation in the clinical study due to safety
concerns with clinical study procedures
- Participants unwilling to abstain from donation of blood during the study
- Participants who plan to travel outside of the United States during the study period
- Women with childbearing potential are not eligible to participate. The study is for
postmenopausal women taking aromatase inhibitors for adjuvant endocrine therapy
- Participants with cognitive impairment are excluded due to dose titration
instructions and completion of questionnaires
- Prospective participants who, in the opinion of the investigator, may not be able to
comply with all study procedures (including compliance issues related to
feasibility/logistics)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa D. Yee
Phone:
626-218-3850
Email:
lyee@coh.org
Investigator:
Last name:
Lisa D. Yee
Email:
Principal Investigator
Start date:
August 15, 2025
Completion date:
August 15, 2026
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Biopharmaceutical Research Company
Agency class:
Other
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06538389
