Trial · NCT06538389
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
NCT06538389, Phase 2, Suspended, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer. Trials, record NCT06538389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06538389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
- NCT number
- NCT06538389
- Status
- Suspended
- Phases
- Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
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
- Interventions
- Biospecimen Collection, BRC-001, Placebo Administration, Questionnaire Administration
- First posted
- 2024-08-05
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Brief Pain Inventory-Short Form (BPI-SF) score | From 0 to 3 months | 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. |
| Secondary | Changes in Visual Analog Scale (VAS) for Pain | From 0 to 3 months | 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. |
| Secondary | Changes in Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES) scores | From 0 to 3 months | 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. |
| Secondary | Incidence of adverse events (AEs) | Up to 30 days after last dose of study treatment | 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. |
| Secondary | Changes in PROMIS Emotional Distress-Anxiety Short Form (SF) 6a Score | From 0 to 3 months | 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. |
| Secondary | Changes in PROMIS Sleep Disturbance Short Form (SF) 4a Score | From 0 to 3 months | The Sleep Disturbance SF 4a is an 8-item tool with questions regarding sleep disturbance. 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 8 to 40 with higher scores indicating greater severity of sleep disturbance. Changes will be summarized by treatment arm. Data will be represented using means/medians. |
| Secondary | Changes in Physical Function by Grip Strength | At 0 and up to 3 months | Grip strength will be quantitated by hand dynamometer (Jarman) at 0 and 3 months. The dominant hand will be recorded for each participant at baseline. This test involves squeezing a dynamometer for 2 to 3 seconds and then releasing. Changes will be summarized by treatment arm. Data will be represented using means/medians. |
| Secondary | Changes in Alanine Aminotransferase (ALT) | At 0, 1, and 3 months | Blood samples will be obtained for testing of alanine transaminase (ALT). An increased ALT indicates a sign of liver dysfunction. Changes will be summarized by treatment arm. Data will be represented using means/medians. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06538389
GET https://conductscience.org/api/trials/v1/NCT06538389/registered