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Observational Study of Cannabis/Cannabinoid Use in Cancer Patients

This study is looking at how cannabis or cannabinoid use affects cancer-related symptoms in people newly diagnosed with certain cancers. These include breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. You would be eligible if you are 18 or older and planning to receive chemotherapy and/or immune checkpoint inhibitors (like therapies targeting PD-1, PD-L1, or CTLA-4). The study aims to understand the connection between cannabis/cannabinoid use and your symptoms over one year. This is an observational study, meaning researchers will collect information about your experiences rather than giving you a specific treatment.

Study design
This is an observational study planning to enroll 2000 participants. It is not specified if it's randomized or blinded.
What's involved
Participants will complete surveys and have their medical records reviewed. Cancer-related symptoms will be assessed monthly for up to 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after enrollment, with monthly symptom assessments.

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NCT06418204

Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics

Recruiting
Not specifiedAges 18+Observational
Wake Forest University Health Sciences
~2,000 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Non-interventional Study

At a glance

Recruiting sites
467 of 467 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cancer-related symptoms
Measured over Baseline and re-assessed monthly up to 12 months post-enrollment

Conditions

Breast Carcinoma
Colorectal Carcinoma
Lung Non-Small Cell Carcinoma
Melanoma
Non-Hodgkin Lymphoma

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Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaMelanomaNon-Hodgkin LymphomaSolid Neoplasm

Where it's being run

467 sites across 44 states
Wisconsin64
Illinois48
California41
Minnesota34
North Carolina24
Michigan22
South Carolina21
Missouri19

Study leadership

  • Glenn Lesser, MD · STUDY_CHAIR · Wake Forest University Health Sciences

Who to contact

Karen Craver
[email protected]
336-716-0891
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.
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.

What this trial measures

  • Cancer-related symptomsBaseline 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.