Nausea Clinical Trial
Official title:
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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