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| ID | Type | Description | Link |
|---|---|---|---|
| 7136-05-6R0 | Other Identifier | Duke legacy protocol number |
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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Rate | Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events | Two months |
| Unacceptable Toxicity Rate | Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Quality of Life -- FACT-Br | The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah H Allen, MSN, RN, CNS, FNP-BC, AOCNP | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preston Robert Tisch Brain Tumor Center at Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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Patients were accrued between May 2006 and June 2009 within the clinic at Duke Comprehensive Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dronabinol | Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dronabinol | Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerability Rate | Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events | 25 of the 33 patients treated with Dronabinol completed 2 cycles of protocol treatment or terminated protocol treatment due to adverse events. The remaining 8 patients are excluded from this tabulation as they terminated Dronabinol treatment before completion of 2 cycles of treatment for reasons unrelated to adverse events. | Posted | Number | 95% Confidence Interval | percentage of participants | Two months |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dronabinol | Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah H. Allen, MSN, RN, CNS, FNP-BC, AOCNP | Duke University | (919) 681-4719 | allen079@mc.duke.edu |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| baseline and 2 months |
| Mean Change From Baseline in Quality of Life -- FLIE | The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54. | baseline, 24 hours, and 72 hours |
| Mean Change From Baseline in Quality of Life -- MMSE | The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function. | baseline and 2 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Unacceptable Toxicity Rate | Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities | All treated patients | Posted | Number | 95% Confidence Interval | percentage of participants | 2 months |
|
|
|
| Secondary | Mean Change From Baseline in Quality of Life -- FACT-Br | The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76. | 19 patients provided both baseline and follow-up assessments; however, only 11 patients provided adequate information to compute the score for the additional brain cancer specific concerns subscale. | Posted | Mean | Standard Deviation | units on a scale | baseline and 2 months |
|
|
|
| Secondary | Mean Change From Baseline in Quality of Life -- FLIE | The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54. | For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 and 72 hours. | Posted | Mean | Standard Deviation | units on a scale | baseline, 24 hours, and 72 hours |
|
|
|
| Secondary | Mean Change From Baseline in Quality of Life -- MMSE | The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function. | 17 patients provided both a pre- and post-treatment assessment of MMSE. | Posted | Mean | Standard Deviation | units on a scale | baseline and 2 months |
|
|
|
| 1 |
| 33 |
| 12 |
| 33 |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Functional Well-Being (N=19) |
|
| Additional Concerns (N=11) |
|
| Title | Measurements |
|---|---|
|
| Emesis at 72 hours |
|