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

Melanoma Clinical Trial

— COSMIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418204
• Other study ID #: WF-2304
• Secondary ID: NCI-2024-03314WF
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: August 2028

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Karen Craver
• Phone: 336-716-0891
• Email: NCORP[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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) PD-1, PD-L1 or CTLA-4.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patient

• 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) with or without immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage patient before treatment starts, enrollment is allowed from diagnosis up to four weeks after the start of treatment but must be before cycle 2 treatment begins.

• Patients must be able to comprehend English or Spanish (for survey completion).

• Patients 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.

Patient Optional Substudy (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 ICIs PD-1, PDL1 or CTLA.

• Must be enrolled before cycle 1 begins

Exclusion Criteria:

Patient

• Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.

Patient Optional Substudy (available at select sites only):

• Patients with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.).

• Patients with a history of HIV, hepatitis B or hepatitis C.

• Patients with active infection who are receiving antibiotic, antifungal or antiviral treatment.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Colorectal Carcinoma
• Colorectal Neoplasms
• Lung Non-Small Cell Carcinoma
• Melanoma
• Non-Hodgkin Lymphoma

Intervention

Other:
• Non-interventional Study
Non-interventional study

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-related symptoms	Will use the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure cancer-related symptoms. Will examine the longitudinal relationship between cannabis and/or cannabinoid use and the likelihood of exhibiting individual symptoms using three-level GLMMs to account for the nested data. We will model continuous measures (e.g., symptom severity) using a linear generalized linear mixed-effects models (GLMM) and the prevalence of symptoms or moderate to severe symptoms using a logistic GLMM. Cannabis and/or cannabinoid use at each monthly assessment will be included as a time-varying covariate and an interaction with time will be included to assess its impact on symptoms over time. Analyses will consider dichotomous definitions of use (yes/no past month), frequency of use (# days in the past month) as well as mode of administration, dose/potency, and cannabinoid type.	Baseline and re-assessed monthly up to 12 months post-enrollment
Secondary	Cannabis and Cannabinoid Use from Cannabis Engagement Assessment	Cannabis and cannabinoid use will be measured monthly using items from the Cannabis Engagement Assessment (CEA). The CEA contains 30 questions that assess the quantity, frequency of use, and method of consumption for dried cannabis products (excluding edibles), cannabis concentrates, and edible products in the previous 30 days. Two additional sections assess other factors associated with cannabis use and history of use. Estimates of consumption can be calculated from responses, with a lower limit of 0 and no upper limit. Higher values represent higher consumption in that month.	Baseline and re-assessed monthly up to 12 months post-enrollment
Secondary	Cannabis and Cannabinoid Use from the International Cannabis Policy Study survey	Cannabis and cannabinoid use will be measured monthly using items from the International Cannabis Policy Study (ICPS) survey. The ICPS surveys provide a comprehensive assessment of cannabis use, includes detailed patterns of consumption, purchasing, adverse outcomes, as well as attitudes and beliefs towards cannabis. Results from this survey will help quantify amount of cannabis use, if any.	Baseline and re-assessed monthly up to 12 months post-enrollment
Secondary	Cannabis and Cannabinoid Perceived Benefits and Harms	The NCI Cannabis Core Measures survey will be used to ask cannabis and cannabinoid users each month whether they think cannabis or cannabinoid use worsened or improved their symptoms. Using the NCI Cannabis Core Measures survey, we will ask cannabis and cannabinoid users each month whether they think cannabis or cannabinoid use worsened or improved their symptoms. We will define this as a nominal outcome where 0=no change; 1=worsened quite a bit or somewhat worsened, and 2=somewhat improved or improved quite a bit.	Baseline and re-assessed monthly up to 12 months post-enrollment
Secondary	Cannabis and Cannabinoid Adverse Effects	The Adverse Reactions Scale will be used to ask cannabis and cannabinoid users each month whether they have experienced a checklist of potential adverse reactions. We will participants using cannabis and/or cannabinoids each month whether they have experienced a checklist of potential adverse reactions. These are defined as presence or absence of the adverse effect. We will also consider the frequency of time they experience the effect (% of time they experience the effect when consuming cannabis or cannabinoids) and the severity of the effect (0 = Not at all distressing; 1 = Mildly distressing; 2 = Moderately distressing; 3 = Quite distressing 4 = Severely distressing) as continuous measures.	Baseline and re-assessed monthly up to 12 months post-enrollment