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

Status
Active
Cancer Type
Breast Cancer
Colon/Rectal Cancer
Lung Cancer
Lymphoma
Melanoma
Non-Hodgkin Lymphoma
Solid Tumor
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Supportive care
NCT ID
NCT06418204
Protocol IDs
WF2304-A172401 (primary)
WF2304-A172401
WF2304-A172401
NCI-2024-03314
Study Sponsor
Wake Forest NCORP Research Base

Summary

This study evaluates complementary approaches (e.g use of substances such as cannabis or dietary supplements, as well as therapies like acupuncture or meditation) that patients use to manage cancer-related symptoms during active treatment for breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer.

Objectives

PRIMARY OBJECTIVE:
I. 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) targeting PD-1, PD-L1 or CTLA-4.

OUTLINE: This is an observational study.

Patients complete surveys and have their medical records reviewed and may optionally undergo blood sample collection on study.

Eligibility

  1. * 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). * Participant must have a working email address and 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. SUBSTUDY: * Must be willing to participate in both the main study and the sub-study at the VA010, VA205, NC002, NC042, NC132, NC246 or NC275 site. * Must be receiving treatment at the VA010, VA205, NC002, NC042, NC132, NC246 or NC275 site. * 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) targeting PD-1, PD-L1 or CTLA-4.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.