A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
This study seeks to define the tolerability and safety associated with the administration of Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients with primary gliomas who are undergoing chemotherapy treatment. The study will also describe the effect of Dronabinol on the quality of life in terms of nausea, vomiting and anorexia in this patient group.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas|
- Tolerability Rate and absence of toxicity [ Time Frame: Two cycles of chemotherapy ] [ Designated as safety issue: Yes ]
- Quality of Life measurements [ Time Frame: Two cycles of chemotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||April 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy
Other Name: delta-9-Tetrahydrocannabinol
Symptoms identified as impacting quality of life include nausea and vomiting, appetite changes, pain, fatigue, mobility, insomnia, mood, bowel patterns, concentration and appearance (Donaldson and Fields, 1998). There has been little information published on the impact of these symptoms in the glioblastoma multiforme (GBM) population. More specifically, to date, there has not been an investigation that demonstrates the efficacy of an intervention on improving appetite, and decreasing nausea and vomiting in patients with GBM. This need serves as the basis for the current proposed investigation utilizing Dronabinol, a cannabinoid known to decrease incidence of nausea and vomiting, as well as controlling appetite changes for terminally ill patients receiving chemotherapy. In addition, there is no published research on the use of Dronabinol and dose limited toxicity for the brain tumor population.
In this study, patients will receive daily Dronabinol therapy through their chemotherapy cycle. Patients will complete daily appetite and nausea/vomiting logs, as well as receive telephone follow-up from the research coordinator to assess impact of treatment. This will be assessed through two consecutive cycles of chemotherapy.
|United States, North Carolina|
|Preston Robert Tisch Brain Tumor Center at Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Deborah H Allen, MSN, ARN, BC||Duke University|