Trials
Search / Trial NCT06418204

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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · May 15, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of cannabis and cannabinoids—substances found in marijuana—on patients who have just been diagnosed with certain types of cancer, such as breast, colorectal, lung, melanoma, and non-Hodgkin lymphoma. The goal is to understand both the benefits and potential risks of using these substances while patients are receiving their cancer treatments, which may include chemotherapy or other targeted therapies.

To participate, you need to be at least 18 years old and have recently been diagnosed with one of the specified types of cancer, planning to start treatment soon. You should also be comfortable completing surveys in English or Spanish, which can be done online from home or in the clinic. If you choose to join, you’ll share your experiences regarding cannabis use and how it affects your treatment. This trial is currently recruiting participants, and it’s important to note that if you are already involved in another treatment study for managing cancer symptoms, you won't be eligible. Overall, your participation could help provide valuable insights into how cannabis might impact cancer treatment for future patients.

Gender

ALL

Eligibility 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.
  • 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.

Trial Officials

Glenn Lesser, MD

Study Chair

Wake Forest University Health Sciences

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Effingham, Illinois, United States

Wisconsin Rapids, Wisconsin, United States

Springfield, Illinois, United States

Saint Louis, Missouri, United States

Billings, Montana, United States

Green Bay, Wisconsin, United States

Marshfield, Wisconsin, United States

Decatur, Illinois, United States

Ottawa, Illinois, United States

Galesburg, Illinois, United States

Springfield, Missouri, United States

Billings, Montana, United States

Green Bay, Wisconsin, United States

Oconto Falls, Wisconsin, United States

Rice Lake, Wisconsin, United States

Wausau, Wisconsin, United States

Weston, Wisconsin, United States

Newark, Ohio, United States

Wausau, Wisconsin, United States

Chippewa Falls, Wisconsin, United States

Canton, Illinois, United States

Carthage, Illinois, United States

Eureka, Illinois, United States

Kewanee, Illinois, United States

Macomb, Illinois, United States

Peru, Illinois, United States

Princeton, Illinois, United States

Boise, Idaho, United States

Joplin, Missouri, United States

Fort Smith, Arkansas, United States

Post Falls, Idaho, United States

Bloomington, Illinois, United States

Pekin, Illinois, United States

Saint Louis, Missouri, United States

Wisconsin Rapids, Wisconsin, United States

Oklahoma City, Oklahoma, United States

Springfield, Illinois, United States

Great Falls, Montana, United States

Caldwell, Idaho, United States

Coeur D'alene, Idaho, United States

Anaconda, Montana, United States

Bardstown, Kentucky, United States

Lexington, Kentucky, United States

Centralia, Illinois, United States

Decatur, Illinois, United States

O'fallon, Illinois, United States

Sullivan, Missouri, United States

Eau Claire, Wisconsin, United States

Stevens Point, Wisconsin, United States

Medford, Wisconsin, United States

Dixon, Illinois, United States

Washington, Illinois, United States

Farmington, Missouri, United States

Bozeman, Montana, United States

Missoula, Montana, United States

Springfield, Illinois, United States

Antigo, Wisconsin, United States

Sheboygan, Wisconsin, United States

Kalispell, Montana, United States

Nampa, Idaho, United States

Ann Arbor, Michigan, United States

Neillsville, Wisconsin, United States

Rhinelander, Wisconsin, United States

Stevens Point, Wisconsin, United States

Ladysmith, Wisconsin, United States

Minocqua, Wisconsin, United States

Sunset Hills, Missouri, United States

O'fallon, Illinois, United States

Escanaba, Michigan, United States

Sandpoint, Idaho, United States

Ontario, Oregon, United States

Winston Salem, North Carolina, United States

Havre, Montana, United States

Iron Mountain, Michigan, United States

London, Kentucky, United States

Sainte Genevieve, Missouri, United States

Sheboygan, Wisconsin, United States

Sturgeon Bay, Wisconsin, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0