Solid Tumor, Adult
Conditions
Keywords
Cannabis, Tumors, Observational Study
Brief summary
The goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among cancer patients.
Detailed description
Tightly controlled experimental laboratory studies (e.g., clinical trials with randomization) using Cannabis products available in state-regulated markets are simply, at this point, not possible owing largely to federal law and the University requirements related to the Controlled Substances Act and Drug Free Schools and Communities Act. Because a traditional clinical trial design is not possible given the current federal status of Cannabis products, this investigator will use a patient-oriented, prospective observational design. Specifically, individuals who have already decided to try Cannabis for their cancer treatment-related symptoms will initiate use of an orally administered product they have selected. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. The participants will then purchase the product and decide how often and how much to use. This approach is consistent with federal law and supported by our preliminary and ongoing studies(1R01AT009541-01, 1R01DA044131-01, CDPHE2902, R01DA039707). Patients will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks, at which time they will be scheduled for an acute administration session (Ta1-Tc1) so that we may examine the acute effects of the product. The final follow-up will be one month later via an online survey sent directly to the participant via email.
Interventions
None listed
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be a female or male aged at least 21 years. 4. Have a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment 5. Have intent or interest to use cannabis to treat their symptoms.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Report of other non-prescription drug use, such as cocaine, heroin, methamphetamine in the past 60 days 2. Actively seeking or in treatment for any substance use disorder 3. Acute illness other than cancer that could affect cognition or compliance per the decision of the study M.D. 4. Premenopausal females who are pregnant or trying to become pregnant. Note that pregnancy testing will not be required. 5. A Telephone Interview for Cognitive Status (TICS) score indicating moderate or severe cognitive impairment at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of Accruing Participants: Feasibility of Enrollment | Approximately 48 months | Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within 54 months of active recruiting. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Amount of Interest | Approximately 48 months | Study officials will document how many patients contact the research team regarding their participation in the study |
| Eligibility | Approximately 48 months | Study officials will document how many patients are and are not eligible to participate in the study. |
| Enrollment | Approximately 48 months | Study officials will document how many patients actually proceed to enrollment in the study. |
| Completion of Assessments | Baseline to one month follow up, Approximately 48 months | Study officials will document how many participants complete each assessment (baseline assessment, pre-acute cannabis use assessment, 1 hour post-acute cannabis use, 2 hour post-acute cannabis use, one month follow up assessment). |
| Study Completion | Approximately 48 months | Study officials will document how many participants complete the study in its entirety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Cannabis This is an observational study of individuals who have already decided to try cannabis for their cancer treatment-related symptoms. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. Participants will then initiate use of an orally administered product they have selected and obtained. Participants will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Oral Cannabis |
|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 15.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 1 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Likelihood of Accruing Participants: Feasibility of Enrollment
Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within 54 months of active recruiting.
Time frame: Approximately 48 months
Population: Number of participants assessed for enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Cannabis | Likelihood of Accruing Participants: Feasibility of Enrollment | Enrolled | 27 Participants |
| Oral Cannabis | Likelihood of Accruing Participants: Feasibility of Enrollment | Completed study | 24 Participants |
Other Pre-specified
Amount of Interest
Study officials will document how many patients contact the research team regarding their participation in the study
Time frame: Approximately 48 months
Population: Number of individuals who contacted the research team about participation in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Cannabis | Amount of Interest | 134 Participants |
Other Pre-specified
Completion of Assessments
Study officials will document how many participants complete each assessment (baseline assessment, pre-acute cannabis use assessment, 1 hour post-acute cannabis use, 2 hour post-acute cannabis use, one month follow up assessment).
Time frame: Baseline to one month follow up, Approximately 48 months
Population: Number of participants enrolled
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Cannabis | Completion of Assessments | Completed baseline assessment | 27 Participants |
| Oral Cannabis | Completion of Assessments | Completed pre-acute cannabis use assessment | 25 Participants |
| Oral Cannabis | Completion of Assessments | Completed 1 hour post-acute cannabis use assessment | 25 Participants |
| Oral Cannabis | Completion of Assessments | Completed 2 hour post-acute cannabis use assessment | 25 Participants |
| Oral Cannabis | Completion of Assessments | Completed one month follow up assessment | 24 Participants |
Other Pre-specified
Eligibility
Study officials will document how many patients are and are not eligible to participate in the study.
Time frame: Approximately 48 months
Population: Number of individuals who contacted the research team about participation in the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Cannabis | Eligibility | Eligible after pre-screening | 41 Participants |
| Oral Cannabis | Eligibility | Not eligible after pre-screening | 5 Participants |
| Oral Cannabis | Eligibility | Did not complete pre-screening | 88 Participants |
Other Pre-specified
Enrollment
Study officials will document how many patients actually proceed to enrollment in the study.
Time frame: Approximately 48 months
Population: Number of individuals found eligible after pre-screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Cannabis | Enrollment | Enrolled | 27 Participants |
| Oral Cannabis | Enrollment | Not enrolled | 14 Participants |
Other Pre-specified
Study Completion
Study officials will document how many participants complete the study in its entirety.
Time frame: Approximately 48 months
Population: Number of participants enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Cannabis | Study Completion | 24 Participants |