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

Recruiting now

Conditions studied: Breast Carcinoma, Colorectal Carcinoma, Lung Non-Small Cell Carcinoma, Melanoma, Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT06418204

Run by

Wake Forest University Health Sciences

People needed

2000

Starts

2025-01-30

Expected to finish

2028-08-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Saint Alphonsus Cancer Care Center-Baker City — Baker City, Oregon, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Ontario — Ontario, Oregon, United States (enrolling)
• Kaiser Permanente Northwest — Portland, Oregon, United States (enrolling)
• Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States (enrolling)
• Lehigh Valley Hospital - Muhlenberg — Bethlehem, Pennsylvania, United States (enrolling)
• WellSpan Medical Oncology and Hematology — Chambersburg, Pennsylvania, United States (enrolling)
• Geisinger Medical Center — Danville, Pennsylvania, United States (enrolling)
• Geisinger Cancer Center Dickson City — Dickson City, Pennsylvania, United States (enrolling)
• Pocono Medical Center — East Stroudsburg, Pennsylvania, United States (enrolling)
• Ephrata Cancer Center — Ephrata, Pennsylvania, United States (enrolling)
• Adams Cancer Center — Gettysburg, Pennsylvania, United States (enrolling)
• Geisinger Medical Center-Cancer Center Hazleton — Hazleton, Pennsylvania, United States (enrolling)
• Lehigh Valley Hospital-Hazleton — Hazleton, Pennsylvania, United States (enrolling)
• Sechler Family Cancer Center — Lebanon, Pennsylvania, United States (enrolling)
• Geisinger Medical Oncology-Lewisburg — Lewisburg, Pennsylvania, United States (enrolling)
• Geisinger Cancer Services-Pottsville — Pottsville, Pennsylvania, United States (enrolling)
• Community Medical Center — Scranton, Pennsylvania, United States (enrolling)
• Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States (enrolling)
• WellSpan Health - York Cancer Center — York, Pennsylvania, United States (enrolling)
• AnMed Health Cancer Center — Anderson, South Carolina, United States (enrolling)
• Beaufort Memorial Hospital — Beaufort, South Carolina, United States (enrolling)
• Saint Joseph's/Candler - Bluffton Campus — Bluffton, South Carolina, United States (enrolling)
• Prisma Health Cancer Institute - Spartanburg — Boiling Springs, South Carolina, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Mercy Hospital Oklahoma City — Oklahoma City, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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