Brain Tumor Clinical Trial
Official title:
Medical Marijuana in the Pediatric Central Nervous System Tumor Population
Verified date | November 2023 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study proposes to do a prospective observational cohort study evaluating the quality of life (QOL) of children with Central Nervous System (CNS) tumors and their families who choose to self-medicate with marijuana-derived products while undergoing treatment at Children's Hospital Colorado (CHCO).
Status | Active, not recruiting |
Enrollment | 19 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. Age > 2 years and < 18 years at the time of study enrollment. 2. Parents/legal guardian(s) that will be completing the questionnaires must sign consent. There are no age parameters for parent/legal guardians' participation on study. 3. Patients must have a diagnosis of central nervous system (brain or spinal) tumor 4. Patients must be ONE of the following: - Undergoing disease-directed therapy or disease surveillance as prescribed by the Pediatric Neuro-Oncology physicians at CHCO - Planning to transfer medical care to Pediatric Neuro-Oncology physicians at CHCO from outside facilities - Receiving palliative care services that are managed in conjunction with physicians at CHCO 5. Interest in marijuana use has been discussed by the patient or parents. 6. Patient has not used any marijuana products or synthetics in the last 14 days (a washout period of 14 days is permitted for those interested in participating on this study) 1. An exception to this rule is if patients took their first dose within 72 hours of signing consent. These patients will be eligible for study without going through a washout period. Exclusion Criteria: 1. Does not meet inclusion criteria 2. Use (or planned use) of synthetic marijuana products as sole cannabinoid therapy |
Country | Name | City | State |
---|---|---|---|
United States | Chilsdren's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Quality of Life | quality-of-life scores as assessed by the validated PedsQL™ brain tumor (PedsQL™-BT) module | 1 year |
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