Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538389
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
High Cannabidiol Plant Extract BRC-001 to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
High Cannabidiol CBD Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None