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Cannabidiol

CBD for Joint Pain in Breast Cancer

Phase 2

Recruiting

Led By Lisa D Yee

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 completed adjuvant chemotherapy as applicable, including systemic chemotherapy, anti-HER2 therapy, and/or radiation therapy

Must not have

Any uncontrolled illness including ongoing or active infection

Known allergies or contraindications to cannabis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 0 and up to 3 months

Summary

"This trial is testing if a plant extract called cannabidiol (CBD) can help reduce joint stiffness and pain in women with breast cancer who are taking aromatase inhibitors (AIs). A

Who is the study for?

This trial is for women with breast cancer experiencing joint pain from aromatase inhibitors. Participants should be postmenopausal and currently on AI therapy. The study excludes those who have used cannabis products recently, are pregnant or breastfeeding, or have conditions that could interfere with the study.

What is being tested?

The trial is testing BRC-001, a high cannabidiol (CBD) plant extract, to see if it can reduce joint stiffness and pain in women taking AIs for breast cancer. It compares BRC-001's effects against a placebo while monitoring through questionnaires and biospecimen collection.

What are the potential side effects?

Potential side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. However, CBD isn't associated with the 'high' of marijuana and isn't habit-forming; specific side effects related to BRC-001 will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is confirmed and not spread beyond stage IIIA.

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I have finished all my required additional cancer treatments.

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My cancer is positive for estrogen and/or progesterone receptors.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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I have had breast cancer surgery and have recovered.

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My worst pain or stiffness is 4 or more on the pain scale, and it started or got worse with AI therapy.

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I have been on a third-generation AI for at least 90 days and plan to continue for 180 more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses or active infections.

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I am allergic to or cannot use cannabis.

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My liver is not working well, with high enzyme levels or bilirubin.

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My kidney function is severely impaired.

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I have not had recent thoughts of harming myself or any past suicide attempts.

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I have a history of seizures.

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I am currently taking CDK 4/6 inhibitors like abemaciclib with AI therapy.

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I do not have any other active cancer.

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I am a postmenopausal woman using aromatase inhibitors for hormone therapy.

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I haven't used cannabis products like CBD or THC in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 0 to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 0 to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Brief Pain Inventory-Short Form (BPI-SF) score

Secondary study objectives

Changes in Alanine Aminotransferase (ALT)

Changes in Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES) scores

Changes in PROMIS Emotional Distress-Anxiety Short Form (SF) 6a Score

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (BRC-001)Experimental Treatment3 Interventions

Participants will be started on a flexible dosing regimen of BC-001, initiating therapy at 200 mg daily and up-titrated based on tolerability over 2 weeks to a maximum of 800 mg daily. Dose increases are recommended to take place in the evening, beginning the evening dose of Day 2. During the Titration Period, study participants may increase the study agent dose every 2 days by 1 mL total (.5 mL per dose) as tolerated. The increment of increase for BRC-001 is 100 mg per 1.0 mL. Patients receive BRC-001 PO BID for up to 3 months. Patients also undergo blood sample collection on study.

Group II: Arm II (Placebo)Placebo Group3 Interventions

Placebo will be self-administered with twice daily doses according to the Titration Period schedule for the first two weeks to the highest tolerable dose up to 4 mL twice daily. Patients receive placebo PO BID for up to 3 months. Patients also undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 18Eligibility criteria met