Examining the effects of cannabis use in cancer patients undergoing treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enroll 2000 newly diagnosed cancer patients, specifically those with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are about to start systemic cancer therapies. Participants will complete monthly surveys and have their medical records reviewed over the course of one year to assess the relationship between cannabis and/or cannabinoid use and cancer-related symptoms. The study is designed to gather data on the benefits and harms of cannabis use in this patient population, providing insights into its impact on treatment outcomes.

Why it matters

Who can join: the full rules

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 planning to receive Immune Checkpoint Inhibitor (ICIs) targeting 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.

Where it's running

• Fairbanks Memorial Hospital
  Fairbanks, Alaska, United States Recruiting
• Kingman Regional Medical Center
  Kingman, Arizona, United States Recruiting
• Cancer Center at Saint Joseph's
  Phoenix, Arizona, United States Recruiting
• Mercy Hospital Fort Smith
  Fort Smith, Arkansas, United States Recruiting
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  Jonesboro, Arkansas, United States Recruiting
• Kaiser Permanente-Deer Valley Medical Center
  Antioch, California, United States Recruiting

+441 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Karen Craver
• Email: NCORP@wfusm.edu
• Phone: 336-716-0891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.