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

Wake Forest University (WFU)

Status: Not yet 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)

WF-2304 (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) 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

Patient

• 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) with or without immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage patient before treatment starts, enrollment is allowed from diagnosis up to four weeks after the start of treatment but must be before cycle 2 treatment begins.
• Patients must be able to comprehend English or Spanish (for survey completion).
• Patients 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.

Patient Optional Substudy (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 ICIs PD-1, PDL1 or CTLA.
• Must be enrolled before cycle 1 begins

Exclusion criteria

Patient

* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.

Patient Optional Substudy (available at select sites only):

• Patients with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.).
• Patients with a history of HIV, hepatitis B or hepatitis C.
• Patients with active infection who are receiving antibiotic, antifungal or antiviral treatment.

Trial design

2,000 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-interventional Study