Cannabis Use for Breast Cancer
(COSMIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how cannabis or cannabinoids might help or harm cancer patients receiving treatments like chemotherapy or immune therapies. It focuses on individuals with newly diagnosed breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. Participants will complete surveys and have their medical records reviewed to assess any impact from cannabis use. The trial suits those starting treatment who live in the U.S., can read English or Spanish, and have email access for surveys. As a Phase 2 trial, this research measures how well cannabis works in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic steroids or immunomodulatory agents, you may not be eligible for the optional sub-study.
Is there any evidence suggesting that cannabis use is likely to be safe for cancer patients?
Research has shown that cannabinoids are usually safe for patients, with few major side effects. In studies with breast cancer patients, cannabinoids like CBD (cannabidiol) have shown promise in slowing cancer cell growth and spread. Another study found that cannabinoids can help manage symptoms and side effects of cancer treatments, such as chemotherapy. As a result, many patients use cannabis to feel better during their treatment. Current research and its common use in cancer care suggest that cannabinoids are safe for use.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how cannabis and cannabinoids might benefit cancer patients, focusing on their real-world effects in community oncology settings. Unlike traditional cancer treatments that typically target the disease directly, this study examines how cannabis could help manage symptoms such as pain, nausea, and anxiety, potentially enhancing patients' quality of life. By gathering data through surveys and medical record reviews, researchers aim to better understand the balance of benefits and harms, offering insights that could lead to more personalized and effective symptom management strategies for cancer patients.
What evidence suggests that cannabis could be effective for cancer treatment?
Studies have shown that cannabidiol (CBD), a substance found in cannabis, can effectively combat cancer. It helps kill cancer cells, slow their growth, and prevent their spread. Research has found that 70%–90% of patients using cannabis for cancer symptoms reported improvement. Another substance, cannabidiolic acid (CBDA), has shown promise in stopping the growth of triple-negative breast cancer. These findings suggest that cannabis and its components might aid in treating certain aspects of breast cancer. Participants in this trial will join an observational study, completing surveys and having their medical records reviewed to further understand the impact of cannabis use in breast cancer.25678
Who Is on the Research Team?
Glenn Lesser, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive systemic cancer-directed therapies with chemotherapy and/or immune checkpoint inhibitors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabis/Cannabinoid
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants complete surveys and have their medical records reviewed on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Cannabidiol as a novel therapeutic agent in breast cancer
CBD demonstrated significant anticancer effects, including induction of apoptosis, inhibition of cell proliferation, suppression of metastasis, ...
Meta-analysis of medical cannabis outcomes and ...
Patient-reported outcome measures indicate that 70%–90% of patients who used cannabis to directly treat cancer symptoms reported improvements, ...
Impact of minor cannabinoids on key pharmacological ...
Another minor cannabinoid with promising potential against breast cancer is cannabidiolic acid (CBDA), which already demonstrated ability to inhibit TNBC cells ...
Cannabidiol as a novel therapeutic agent in breast cancer
CBD demonstrated significant anticancer effects, including induction of apoptosis, inhibition of cell proliferation, suppression of metastasis, ...
A survey of breast cancer patients' use of cannabis before, ...
Post-surgical use was reported in 51% after mastectomy alone, 40% after lumpectomy, and 38% after mastectomy/reconstruction. An average of 3-4 ...
Cannabinoids in Breast Cancer: Differential Susceptibility ...
The results obtained thus far indicate that, generally, cannabinoids are well-tolerated compounds, without significant side effects and with a ...
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acsjournals.onlinelibrary.wiley.com
acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33906A Coala‐T‐Cannabis Survey Study of breast cancer patients ...
The goal of this study was to characterize cannabis use among patients with breast cancer, including their reasons for and timing of use.
Study: Cannabis use among breast cancer patients
This study is about understanding why and how patients with breast cancer use marijuana (cannabis) to help manage treatment symptoms and side effects.
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