NCT06418204 Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
| NCT ID | NCT06418204 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Breast Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2025-01-30 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Glenn Lesser, MD
STUDY CHAIR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT06418204 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06418204 currently recruiting?
Yes, NCT06418204 is actively recruiting participants. Contact the research team at NCORP@wfusm.edu for enrollment information.
Where is the NCT06418204 trial being conducted?
This trial is being conducted at Fairbanks, United States, Kingman, United States, Phoenix, United States, Fort Smith, United States and 11 additional locations.
Who is sponsoring the NCT06418204 clinical trial?
NCT06418204 is sponsored by Wake Forest University Health Sciences. The principal investigator is Glenn Lesser, MD at Wake Forest University Health Sciences. The trial plans to enroll 2,000 participants.