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

RECRUITINGSponsored by Wake Forest University Health Sciences
Actively Recruiting
SponsorWake Forest University Health Sciences
Started2025-01-30
Est. completion2028-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations459 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions8

Breast CancerBreast CarcinomaCancerColorectal CarcinomaLung CancerLung Non-Small Cell CarcinomaMelanomaNon-hodgkin Lymphoma

Locations459 sites

Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Kingman Regional Medical Center
Kingman, Arizona, 86401
702-384-0013research@sncrf.org
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
800-378-9373
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
870-936-7066

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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