CBD for Joint Pain in Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Aromatase inhibitors

Must not be taking: Cannabinoids, Narcotics, Anticonvulsants, others

Disqualifiers: Uncontrolled illness, Major psychiatric illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a plant-based extract called CBD (from the cannabis family but distinct from marijuana) can reduce joint pain and stiffness in women with breast cancer taking aromatase inhibitors (AIs). AIs lower estrogen levels to help prevent breast cancer recurrence but can cause joint pain, leading some women to discontinue use. The trial compares CBD (also known as BRC-001) with a placebo to determine if it can relieve pain without causing a "high." Women who have been on AIs for at least 90 days and experience significant joint pain may qualify to participate. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial requires that you continue taking your current aromatase inhibitor (AI) medication. However, you must stop using any cannabinoid products, certain pain medications, and other specific drugs like warfarin and some anti-epileptics before joining the study.

Is there any evidence suggesting that BRC-001 is likely to be safe for humans?

Studies have shown that CBD (cannabidiol) is generally well-tolerated, typically not causing serious side effects. In research involving patients with hormone receptor-positive breast cancer, CBD proved safe, with few reports of serious issues.

Patients who previously used CBD for joint pain and inflammation reported only mild side effects, such as sleepiness or dry mouth, which are not considered serious. The treatment in this trial, BRC-001, is a special CBD formula designed to safely reduce joint pain in women taking aromatase inhibitors for breast cancer.

Since the trial is in Phase 2, it has already passed early safety tests, providing researchers with some confidence in its safety for humans. However, further testing is needed to better understand how people handle it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for joint pain in breast cancer?

Unlike the standard treatments for joint pain in breast cancer, which often include NSAIDs or opioids, BRC-001 is a new approach because it uses cannabidiol (CBD) as its active ingredient. Researchers are excited about BRC-001 because CBD is believed to offer pain relief without the addictive properties and side effects associated with opioids. Additionally, BRC-001’s flexible dosing regimen allows patients to gradually increase their dose based on personal tolerance, offering a more tailored approach to pain management. This could potentially provide a safer and more effective alternative for managing joint pain in breast cancer patients.

What evidence suggests that BRC-001 might be an effective treatment for joint pain in breast cancer?

Research suggests that CBD may help reduce joint pain and stiffness. Animal studies have shown that CBD lowers inflammation, potentially leading to less joint pain. People with arthritis have also reported reduced pain when using CBD. In this trial, participants in one arm will receive BRC-001, a special CBD plant extract designed to alleviate joint pain, particularly in women taking aromatase inhibitors for breast cancer. While early research appears promising, more studies are needed to confirm these effects specifically for joint pain in women with breast cancer. ^{2 3 4 5 6}

Who Is on the Research Team?

Lisa D Yee, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have been cancer-free from any other cancer than skin or early-stage cancer for over 5 years.

I can read and understand English or Spanish, or I can use an interpreter.

Exclusion Criteria

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)

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 with cognitive impairment are excluded due to dose titration instructions and completion of questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BRC-001 or placebo orally twice daily for up to 3 months. Blood samples are collected during this phase.

12 weeks

Regular visits for blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including assessment of adverse events.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BRC-001

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (BRC-001) Experimental Treatment 3 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 Group 3 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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Biopharmaceutical Research Company

Collaborator

Trials

3

Recruited

100+

Published Research Related to This Trial

In a study of 177 patients with advanced cancer pain, the THC:CBD extract significantly reduced pain more than placebo, with an average improvement of -1.37 on the pain scale compared to -0.69 for placebo.

The THC extract did not show a significant difference in pain relief compared to placebo, indicating that THC:CBD may be more effective for pain management in patients who do not respond adequately to opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. Johnson, JR., Burnell-Nugent, M., Lossignol, D., et al.[2022]

Cannabidiol (CBD) has shown promising anticancer effects in both laboratory studies and animal models, suggesting its potential as a treatment option for cancer.

The review highlights important considerations for CBD's application in cancer therapy, including its interactions with conventional drugs, tolerability, and potential side effects, which are crucial for its safe use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol on the Path from the Lab to the Cancer Patient: Opportunities and Challenges. Olivas-Aguirre, M., Torres-López, L., Villatoro-Gómez, K., et al.[2022]

Cannabinoids, including Δ(9)-THC and cannabidiol (CBD), have shown potential anti-tumor effects by inhibiting cancer cell growth, promoting cell death, and disrupting tumor blood vessel formation and metastasis.

CBD, in particular, is gaining attention as a non-psychoactive alternative to Δ(9)-THC, with the potential to modulate various stages of tumor development across different cancer types, making it a promising candidate for cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as potential anticancer drug. Massi, P., Solinas, M., Cinquina, V., et al.[2021]

The autologous cancer cell vaccine combined with BCG and formalin significantly reduced tumor growth and increased the presence of antitumor immune cells in a murine model of breast cancer, indicating strong antitumor effects.

This vaccine approach not only showed effectiveness in reducing tumor size but also suggested potential activation of immune memory, making it a promising candidate for personalized breast cancer immunotherapy due to its low cost and simple preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous tumor cells/bacillus Calmette-Guérin/formalin-based novel breast cancer vaccine induces an immune antitumor response. Godoy-Calderón, MJ., Salazar, V., González-Marcano, E., et al.[2019]

The combination of ConvitVax, an autologous tumor cell vaccine, with anti-PD-1 therapy showed improved antitumor effects in a breast cancer model, evidenced by increased tumor necrosis and enhanced immune cell infiltration.

This study suggests that combining ConvitVax with checkpoint inhibitors like anti-PD-1 could lead to more effective and personalized breast cancer treatments, especially considering the vaccine's low cost and ease of preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a ConvitVax/anti-PD-1 combined immunotherapy for breast cancer treatment. Godoy-Calderón, MJ., González-Marcano, E., Carballo, J., et al.[2019]

Paclitaxel (Taxol) is a significant new chemotherapy drug for breast cancer, showing promise in both single-agent and combination treatments.

Ongoing research at Memorial Sloan-Kettering Cancer Center aims to optimize the use of paclitaxel in various treatment settings, including metastatic and adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memorial Sloan-Kettering Cancer Center experience with paclitaxel in the treatment of breast cancer. Seidman, AD., Hudis, CA., Fennelly, D., et al.[2015]

Cannabidiol (CBD) enhances the effectiveness of conventional breast cancer treatments, paclitaxel (PTX) and doxorubicin (DOX), showing a synergistic effect in breast cancer cell lines (MCF-7 and MDA-MB-231).

The development of CBD-loaded microparticles (CBD-Mps) not only extended the antiproliferative activity for at least 10 days but also improved the efficacy of PTX and DOX, suggesting that CBD can be effectively integrated into breast cancer chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBD loaded microparticles as a potential formulation to improve paclitaxel and doxorubicin-based chemotherapy in breast cancer. Fraguas-Sánchez, AI., Fernández-Carballido, A., Simancas-Herbada, R., et al.[2020]

Recent advancements in cancer immunotherapy are showing promise in treating various solid tumors, including melanoma, prostate cancer, and lung cancer, by targeting the immune response mechanisms.

Early-phase clinical trials are now exploring the use of tumor antigen vaccines and checkpoint inhibitors to enhance immune responses specifically in breast cancer patients, indicating potential new treatment options for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for the treatment of breast cancer. Ernst, B., Anderson, KS.[2018]

In a mouse model of chemotherapy-induced neuropathic pain, both CBD and THC were effective in reducing mechanical sensitivity, with low doses of each showing a synergistic effect when combined.

CBD demonstrated the ability to alleviate pain from oxaliplatin-induced neuropathy, while THC was effective against vincristine-induced pain, suggesting that combining these cannabinoids could enhance treatment options for chemotherapy-related nerve pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single and combined effects of Δ9 -tetrahydrocannabinol and cannabidiol in a mouse model of chemotherapy-induced neuropathic pain. King, KM., Myers, AM., Soroka-Monzo, AJ., et al.[2021]

Breast cancer immunotherapy, particularly therapeutic vaccines, is being explored as a potential treatment option due to the severe side effects associated with conventional therapies, but no breast cancer vaccine has yet been approved for clinical use.

Current breast cancer vaccine strategies, including protein/peptide, dendritic cell, and genetic vaccines, often fail to provide clinical benefits on their own and are typically used in combination with other treatments like chemotherapy or radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer vaccines as a targeted immunotherapy approach for breast cancer: an update of clinical evidence. Abbaspour, M., Akbari, V.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06538389

NCT06538389 | High Cannabidiol Plant Extract (BRC-001) ... BRC-001 may reduce joint pain in women with breast cancer taking AIs. ... To evaluate indicators of preliminary efficacy of BRC-001 on joint symptoms of pain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316815/

Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor ... Aromatase inhibitor (AI) therapy reduces breast cancer recurrence risk. However, some patients stop treatment early because of AI‐associated ...

3. cityofhope.org cityofhope.org/city-stories-blog/cannabinoid-medical-research

Cannabinoid Product Holds Promise for Patients in Pain Uniquely formulated, BRC-001 also contains other cannabinoids in proprietary, targeted ratios designed to safely and effectively treat aromatase ...

4. trialx.com trialx.com/clinical-trials/listings/308952/high-cannabidiol-plant-extract-brc-001-to-improve-aromatase-inhibitor-induced-arthralgia-in-women-with-breast-cancer/

High Cannabidiol Plant Extract (BRC-001 ... 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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cam4.71117

Pilot Study of Cannabidiol for Treatment of Aromatase ... Aromatase inhibitors (AI) are effective for reducing the risk of breast cancer ... CBD would improve joint pain. However, there was no ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06538389/high-cannabidiol-plant-extract-brc-001-to-improve-aromatase-inhibitor-induced-arthralgia-in-women-with-breast-cancer

High Cannabidiol Plant Extract (BRC-001) to Improve ... This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract ... BRC-001 may reduce joint pain in women with breast cancer