NCT06418204 · Wake Forest University Health Sciences
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
(COSMIC)
What this study is about
This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.
View original scientific description
This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.
Interventions
OTHER
Non-interventional Study
Non-interventional study
Primary outcome measures
Cancer-related symptoms
Time frame: Baseline and re-assessed monthly up to 12 months post-enrollment
Will use the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure cancer-related symptoms. Will examine the longitudinal relationship between cannabis and/or cannabinoid use and the likelihood of exhibiting individual symptoms using three-level GLMMs to account for the nested data. The investigators will model continuous measures (e.g., symptom severity) using a linear generalized linear mixed-effects models (GLMM) and the prevalence of symptoms or moderate to severe symptoms using a logistic GLMM. Cannabis and/or cannabinoid use at each monthly assessment will be included as a time-varying covariate and an interaction with time will be included to assess its impact on symptoms over time. Analyses will consider dichotomous definitions of use (yes/no past month), frequency of use (# days in the past month) as well as mode of administration, dose/potency, and cannabinoid type.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified).
- Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.
- Participants must be able to comprehend English or Spanish (for survey completion).
- Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.
- Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.
- Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey
- In the treating provider's opinion, the participant should have a life expectancy of \>=6 months. Participants in hospice are not eligible. Optional Sub-study (available at select sites only):
- Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).
- Must be receiving treatment at the WF CCC and VCU.
- Must be diagnosed with non-small cell lung cancer.
- Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
Exclusion criteria
- Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.
- Participants with known pregnancy.
- Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy.
- Participants enrolled in hospice. Optional Substudy (available at select sites only):
- Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed.
- Participants with a history of HIV, hepatitis B or hepatitis C.
Where
- Fairbanks, Alaska
- Kingman, Arizona
- Phoenix, Arizona
- Fort Smith, Arkansas
- Jonesboro, Arkansas
- Antioch, California
- Arroyo Grande, California
- Carmichael, California
- Dublin, California
- Elk Grove, California
- Fremont, California
- Fresno, California
And 351 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations