IMmunotherapy: Prospective Assessment of Cannabis Treatment in Cancer
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorState University of New York at Buffalo
About this trial
The purpose of this research is to assess how patients with cancer being treated with Immune Checkpoint Inhibitors (ICI) manage symptoms related to cancer and/or its treatment. Patients use a variety of ways to manage symptoms including traditional and alternative treatments including cannabis, acupuncture, etc. This research will have an important impact on our knowledge of cancer symptom management, and ultimately improve patient care and safety.
Participants will complete online surveys and 7 days of ecological momentary assessments at 0, 1, 2, 4, 6, 9 and 12 month to compare the cannabis users and non cannabis users symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult age of 18 years or older
cancer diagnosis and planning or using immunotherapy treatment,
pain and spend less than 50% in bed or chair
fluent in english language
Disqualifiers
use synthetic cannabis or only use Cannabidiol (CBD)
non users but used in the past 3 months
Patients receiving immunosuppressants or organ transplant recipients.
Patients within 6 months of Hospice care.
Trial population
Adult cancer patients that are treated or plan to be treated with immunotherapy.
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
450 Participants
are grouped into 2 trial groupsGroup A: Cannabis User
Group B: Cannabis non-user
Trial outcomes
Primary outcomes
1
Patient Reported Outcomes Measurement Information System: Pain interference
Pain interference with daily life and enjoyment on a 5 item scale of not at all to very much. Higher score indicates worse outcome.
Time frame
0,1,2,4,6,9 and 12 months2
Patient Reported Outcomes Measurement Information System: Sleep
PROMISE sleep disturbance on a 5 item scale of not at all to very much. Higher score indicates worse outcome.
Time frame
0,1,2,4,6,9 and 12 months3
Patient Reported Outcomes Measurement Information System:Anxiety
Anxiety on a 5 item scale of never to always. Higher score indicates worse outcome. Higher score indicates worse outcome.
Time frame
0,1,2,4,6,9 and 12 months4
Adverse reaction of Cannabis
Adverse reaction to Cannabis Scale of present side effects and 5 item scale of how distressing the symptoms were experienced. Higher score indicates worse outcome.
Time frame
0,1,2,4,6,9 and 12 monthsSecondary outcomes
1
Quality of Life with cancer
Functional Assessment of Cancer Therapy-General. Physical well-being, Social/Family Well being on a 5 item scale of not at all to very much. Higher score indicates worse outcome.
Time frame
0,1,2,4,6,9 and 12 months2
Area Deprivation Index
Test cannabis use association with Area Deprivation Index (ADI) and the benefits and harms. The Area Deprivation Index Its composite score combines key indicators of socioeconomic status, such as income, education, employment, and housing quality, and is weighted and standardized to create an overall score for each neighborhood (0-100 percentile), with higher scores indicating a higher degree of disadvantage.
Time frame
0, 2, 6, and 12Other outcomes
1
Immunological markers
Blood draws to test inflammatory markers. Luminex multiplex assays use xMAP bead-based technology to simultaneously detect and quantitate multiple secreted proteins including cytokines, chemokines, and growth factors in a single sample. The Luminex® xMAP® technology uses color-coded beads coupled with target-specific antibodies allowing the detection of up to 100 soluble analytes in a single 20 ul sample.
Time frame
0, 2, 6 and 12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
State University of New York at Buffalo
Lead sponsor
Thomas Jefferson University
Collaborator
Oregon Health and Science University
Collaborator
Source ClinicalTrials.gov