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

ConditionsAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Breast AdenocarcinomaBreast Ductal Carcinoma In SituEstrogen Receptor-Positive Breast CarcinomaProgesterone Receptor-Positive Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCity of Hope Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

< 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • BRC-001

    Drug

    Given PO

  • Placebo Administration

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Arm I (BRC-001)Experimental treatment 3 interventions
Group B: Arm II (Placebo)Placebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From 0 to 3 months

Secondary outcomes

1

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.

Time frame
From 0 to 3 months
2

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.

Time frame
From 0 to 3 months
3

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.

Time frame
Up to 30 days after last dose of study treatment
4

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.

Time frame
From 0 to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Biopharmaceutical Research Company

Collaborator

Source ClinicalTrials.gov
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