Study on a Hemp-Derived High CBD Product for Anxiety in Glioblastoma Patients

Sponsor: Mclean Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05753007

Provider View

This clinical trial is testing a hemp-derived product with high levels of cannabidiol (CBD) to see if it can help reduce anxiety, pain, and improve quality of life in patients with newly diagnosed glioblastoma, a type of brain cancer. The study will also look at whether this product affects tumor growth.

Patient Parameters

Program Overview

Glioblastoma is a common and aggressive brain tumor in adults, often leading to anxiety, depression, pain, and sleep problems, which affect patients' quality of life. Cannabidiol (CBD), a compound found in hemp, has shown promise in easing these symptoms without major side effects. This study will test a specially formulated CBD product to see if it can help with anxiety, pain, and quality of life in glioblastoma patients who are receiving standard treatments. The study will also check if the CBD product has any effect on the tumor's growth. Participants will be randomly assigned to receive either the CBD product or a placebo for 8 weeks, and neither the participants nor the researchers will know who is receiving which treatment until the study ends.

Eligibility Criteria

Inclusion Criteria

  • Have a new diagnosis of glioblastoma, confirmed by medical tests, and are about to start standard treatment with radiation and temozolomide (patients using Optune can join).
  • Able to give written consent to participate in the study or have a legal representative do so.
  • Can understand and speak English.
  • Experience at least moderate anxiety levels as measured by specific tests during the screening visit.
  • Have been on stable medication or therapy for at least one month before starting the study (except for new treatments related to glioblastoma).
  • Have a Karnofsky Performance Scale (KPS) score of 60 or higher, indicating they can care for themselves with some help.

Exclusion Criteria

  • Pregnant, breastfeeding, or not willing to use birth control during the study.
  • Have a condition that the researchers believe could affect safety or data quality.
  • Have a current substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.
  • Use recreational or medical cannabis, or hemp-derived products more than once a month, or test positive for THC in urine.
  • Have a serious or unstable medical condition, such as liver, kidney, or heart disease.
  • Currently taking valproate due to possible drug interactions.
  • Participating in other research studies or clinical trials with treatments.
  • Have liver enzyme levels more than three times the normal limit within 24 hours before starting treatment.
  • Have a condition that prevents having an MRI, like certain medical devices or metal in the body.

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