Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Recruiting · NCT06418204 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Non-interventional Study
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
- ptional 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.
- ptional 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 is running
60 locations listed across 42 US states.
- Fairbanks Memorial Hospital - Fairbanks, Alaska, United States
- Fairbanks Memorial Hospital - Fairbanks, Alaska, United States
- Kingman Regional Medical Center - Kingman, Arizona, United States
- Kingman Regional Medical Center - Kingman, Arizona, United States
- Cancer Center at Saint Joseph's - Phoenix, Arizona, United States
- Cancer Center at Saint Joseph's - Phoenix, Arizona, United States
- Mercy Hospital Fort Smith - Fort Smith, Arkansas, United States
- Mercy Hospital Fort Smith - Fort Smith, Arkansas, United States
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro, Arkansas, United States
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro, Arkansas, United States
- Kaiser Permanente-Deer Valley Medical Center - Antioch, California, United States
- Kaiser Permanente-Deer Valley Medical Center - Antioch, California, United States
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande, California, United States
- PCR Oncology - Arroyo Grande, California, United States
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande, California, United States
- PCR Oncology - Arroyo Grande, California, United States
- Mercy Cancer Center - Carmichael - Carmichael, California, United States
- Mercy San Juan Medical Center - Carmichael, California, United States
- Mercy Cancer Center - Carmichael - Carmichael, California, United States
- Mercy San Juan Medical Center - Carmichael, California, United States
- Kaiser Permanente Dublin - Dublin, California, United States
- Kaiser Permanente Dublin - Dublin, California, United States
- Mercy Cancer Center - Elk Grove - Elk Grove, California, United States
- Mercy Cancer Center - Elk Grove - Elk Grove, California, United States
- Kaiser Permanente-Fremont - Fremont, California, United States
- Kaiser Permanente-Fremont - Fremont, California, United States
- Kaiser Permanente Fresno Orchard Plaza - Fresno, California, United States
- Kaiser Permanente-Fresno - Fresno, California, United States
- Saint Agnes Medical Center - Fresno, California, United States
- Saint Helena Hospital - Fresno, California, United States
- Kaiser Permanente Fresno Orchard Plaza - Fresno, California, United States
- Kaiser Permanente-Fresno - Fresno, California, United States
- Saint Agnes Medical Center - Fresno, California, United States
- Saint Helena Hospital - Fresno, California, United States
- Contra Costa Regional Medical Center - Martinez, California, United States
- Contra Costa Regional Medical Center - Martinez, California, United States
- Contra Costa Regional Medical Center - Martinez, California, United States
- Contra Costa Regional Medical Center - Martinez, California, United States
- Kaiser Permanente- Modesto MOB II - Modesto, California, United States
- Kaiser Permanente-Modesto - Modesto, California, United States
- Kaiser Permanente- Modesto MOB II - Modesto, California, United States
- Kaiser Permanente-Modesto - Modesto, California, United States
- Kaiser Permanente-Oakland - Oakland, California, United States
- Kaiser Permanente-Oakland - Oakland, California, United States
- Kaiser Permanente- Marshall Medical Offices - Redwood City, California, United States
- Kaiser Permanente- Marshall Medical Offices - Redwood City, California, United States
- Kaiser Permanente-Richmond - Richmond, California, United States
- Kaiser Permanente-Richmond - Richmond, California, United States
- Mercy Cancer Center - Rocklin - Rocklin, California, United States
- Mercy Cancer Center - Rocklin - Rocklin, California, United States
- Kaiser Permanente-Roseville - Roseville, California, United States
- Kaiser Permanente-Roseville - Roseville, California, United States
- Kaiser Permanente Downtown Commons - Sacramento, California, United States
- Mercy Cancer Center - Sacramento - Sacramento, California, United States
- Kaiser Permanente-South Sacramento - Sacramento, California, United States
- Kaiser Permanente Downtown Commons - Sacramento, California, United States
- Mercy Cancer Center - Sacramento - Sacramento, California, United States
- Kaiser Permanente-South Sacramento - Sacramento, California, United States
- Kaiser Permanente-San Francisco - San Francisco, California, United States
- Kaiser Permanente-San Francisco - San Francisco, California, United States
Showing 60 of 934 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →