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Examining the effects of cannabis use in cancer patients undergoing treatment

Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics

Observational Wake Forest University Health Sciences · NCT06418204

This study is trying to see how using cannabis affects newly diagnosed cancer patients who are starting treatment for their illness.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorWake Forest University Health Sciences Academic / other
Drugs / interventionsinfliximab, chemotherapy, immunotherapy, prednisone
Locations467 sites (Fairbanks, Alaska and 466 other locations)
Trial IDNCT06418204 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic chemotherapy or immune checkpoint inhibitors.

Not a fit: Patients who are not newly diagnosed with the specified cancers or those not planning to undergo systemic cancer-directed therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the potential benefits and risks of cannabis use for cancer patients undergoing treatment.

How similar studies have performed: While there is ongoing interest in the effects of cannabis in cancer care, this study's specific focus on newly diagnosed patients undergoing systemic therapies is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fairbanks, Alaska and 466 other locations

+417 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaMelanomaNon-Hodgkin Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.