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

Wake Forest University (WFU)

Status

Enrolling

Conditions

Colorectal Carcinoma

Melanoma

Breast Carcinoma

Lung Non-Small Cell Carcinoma

Non-Hodgkin Lymphoma

Treatments

Other: Non-interventional Study

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT06418204

1U01CA286813 (U.S. NIH Grant/Contract)

5UG1CA189824 (U.S. NIH Grant/Contract)

IRB00122898

WF2304-A172401 (Other Identifier)

NCI-2024-03314 (Other Identifier)

Details and patient eligibility

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.

Full description

The objective of this study is to examine the association between cannabis and/or cannabinoid use and cancer-related symptoms assessed monthly for one year in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning or recently started to receive one or more systemic cancer directed therapies with chemotherapy and/or immune check point inhibitors (ICIs) targeting PD-1, PD-L1 or CTLA-4.

Participants complete surveys and have their medical records reviewed on study.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
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.

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 receiving paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
Must be enrolled and complete baseline survey before cycle 1 begins

Exclusion criteria

Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.
Participants with known pregnancy.

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.