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Medical Marijuana in the Pediatric Central Nervous System Tumor Population

Sponsor
University of Colorado, Denver (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03052738
Collaborator
(none)
19
Enrollment
1
Location
77.5
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Children's Hospital Colorado (CHCO) Center for Cancer and Blood Disorders (CCBD) is a national leader in pediatric cancer therapy. The CHCO Neuro-Oncology program treats more that 90% of Coloradan children with Central Nervous System (CNS) tumors and a large percentage of children with CNS tumors from the surrounding five states. Due to advances in therapy, approximately two-thirds of children with CNS tumors treated at CHCO will be cured. Although medical marijuana has been legal for more than a decade in Colorado, the publicity around the more recent legalization for general adult use, increasing literature, and anecdotal reports of patients with terminal CNS tumors cured with medical marijuana, have prompted a recent increase in interest of current CHCO patients and their families. There has been an influx of pediatric cancer patients and their families moving to Colorado to obtain these marijuana-based products to self-medicate.

    The Investigators will administer PedsQLTM questionnaires and diaries to gather data regarding use practices, method of delivery, strain used, dosing and frequency, and family financial impact on all enrolled patients. The Investigators will also collect peripheral blood samples to evaluate for evidence of immuno-modulation by cannabinoids in patients who may already be immunocompromised and to assess blood cannabinoid levels.

    This study will provide novel exploratory data regarding use patterns, impact on families and resources, and potential clinical benefits and harms associated with the growing marijuana use in the pediatric neuro-oncology population. Such information may guide future children afflicted with CNS tumors and their families to make decisions about whether to pursue cannabinoid treatment.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    19 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Medical Marijuana in the Pediatric Central Nervous System Tumor Population
    Actual Study Start Date :
    Jan 15, 2016
    Actual Primary Completion Date :
    Jun 30, 2020
    Anticipated Study Completion Date :
    Jun 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Overall Quality of Life [1 year]

      quality-of-life scores as assessed by the validated PedsQL™ brain tumor (PedsQL™-BT) module

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Interest in marijuana use has been discussed by the patient or parents.

    2. 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)

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chilsdren's Hospital Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Nicholas K Foreman, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT03052738
    Other Study ID Numbers:
    • 15-0404.cc
    First Posted:
    Feb 14, 2017
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    central nervous system (brain or spinal) tumor
    Additional relevant MeSH terms:
    Neoplasms
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Spinal Cord Neoplasms
    Spinal Neoplasms

    Study Results

    No Results Posted as of Nov 10, 2021