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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
Solvay Pharmaceuticals |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00314808 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Neoplasms Nausea Vomiting |
Drug: Dronabinol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas |
| Estimated Enrollment: | 38 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Deborah H Allen, MSN, ARN, BC | 919-681-4719 | allen079@mc.duke.edu |
| Contact: Waynette Freeman, RN | 919-684-3440 | Freem050@mc.duke.edu |
| United States, North Carolina | |
| Preston Robert Tisch Brain Tumor Center at Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Deborah H Allen, MSN, ARN, BC 919-681-4719 allen079@mc.duke.edu | |
| Contact: Waynette Freeman, RN 919-684-3440 Freem050@mc.duke.edu | |
| Principal Investigator: Deborah H Allen, MSN, ARN, BC | |
| Principal Investigator: | Deborah H Allen, MSN, ARN, BC | Duke University |
More Information
| Responsible Party: | Duke University Medical Center/Preston Robert Tisch Brain Tumor Center ( Deborah H Allen, MSN,RN,CNS,FNP-BC,AOCNP ) |
| Study ID Numbers: | 7136-05-6R0/00007559 |
| Study First Received: | April 13, 2006 |
| Last Updated: | December 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00314808 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
primary gliomas brain tumors vomiting appetite suppression appetite |
|
Vomiting Signs and Symptoms, Digestive Neoplasms, Nerve Tissue Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Central Nervous System Neoplasms Brain Diseases Signs and Symptoms Neoplasms by Site Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Analgesics Glioma |
Nervous System Neoplasms Neoplasms by Histologic Type Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Tetrahydrocannabinol Neuroectodermal Tumors Brain Neoplasms Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Neoplasms, Neuroepithelial Central Nervous System Agents Neoplasms, Glandular and Epithelial |