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

Get Involved

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06418204
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Wake Forest University Health Sciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Glenn Lesser, MD
Principal Investigator Affiliation	Wake Forest University Health Sciences
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Carcinoma, Colorectal Carcinoma, Lung Non-Small Cell Carcinoma, Melanoma, Non-Hodgkin Lymphoma

Additional Details

The objective of this study is 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. Participants complete surveys and have their medical records reviewed on study.

Arms & Interventions

Arms

: Observational

Participants complete surveys and have their medical records reviewed on study.

Interventions

Other: - Non-interventional Study

Non-interventional study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fairbanks Memorial Hospital, Fairbanks 5861897, Alaska 5879092

Status

Recruiting

Address

Fairbanks Memorial Hospital

Fairbanks 5861897, Alaska 5879092, 99701

Site Contact

Clinical Trial Finder