A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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.
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 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.
We found this trial at
1
site
Durham, North Carolina 27710
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